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ICU MEDICAL, INC.

United States·US-MF-000002566

Last updated September 17, 2026

What ICU MEDICAL, INC. makes

ICU Medical, Inc. manufactures tracheostomy tubes (both reinforced and non-reinforced, reusable and single-use), accessories for tracheostomy care such as straps, tube holders, and inner cannula cleaning swabs, intravenous administration sets (basic and extension tubing), invasive-pressure external transducers, mechanical pipettes, and medicated epidural anaesthesia sets.

The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 951, Calle Amanecer, San Clemente, United States
Website: www.icumed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 949 366 2183
PRRC Contact: Joe Canavan
EUDAMED SRN: US-MF-000002566
FDA FEI Number: 3013319212
DUNS Number: 118380146

Catalogue (61990)

Page 2 of 500

Device	Model / Reference	Registries	Class	Status
Bivona	FT18GN40NSA104N	FDA UDI	Class II	Active
ICU Medical	46200-64	FDA UDI	Class II	Active
ICU Medical	MR4R10	FDA UDI	Class II	Active
ICU Medical	MC330580	FDA UDI	Class II	Active
ICU Medical	B55023	FDA UDI	Class II	Active
Bivona	ST16EN55NGF191N	FDA UDI	Class II	Active
Cadd	21-2120-0102-02	FDA UDI	Class II	Active
ICU Medical	SC9080	FDA UDI	Class II	Active
Bivona	FT24BN40NSE086N	FDA UDI	Class II	Active
Bivona	FT24BN35NSA026N	FDA UDI	Class II	Active
Bivona	FT23HN40NSA139N	FDA UDI	Class II	Active
Bivona	FT19CN35NGC911N	FDA UDI	Class II	Active
Bivona	FT19DN65NSC092N	FDA UDI	Class II	Active
Bivona	FP16LN30NGE996N	FDA UDI	Class II	Active
Bivona	HT12FS40NSC183N	FDA UDI	Class II	Active
Bivona	FT14JN40NSF038N	FDA UDI	Class II	Active
Bivona	FU13HN30NSA326N	FDA UDI	Class II	Active
Bivona	FT12FN40NSF073N	FDA UDI	Class II	Active
Bivona	HA24BS70NSC257N	FDA UDI	Class II	Active
Bivona	FU23FN40NSE063N	FDA UDI	Class II	Active
Bivona	FT19GN45NGF167N	FDA UDI	Class II	Active
Bivona	CM3102N	FDA UDI	Class II	Active
Bivona	FT17KN40NGE980N	FDA UDI	Class II	Active
Bivona	ST17GN60NSB050N	FDA UDI	Class II	Active
Bivona	FU17HN40NGE833N	FDA UDI	Class II	Active
Bivona	FU14IN30NSF301N	FDA UDI	Class II	Active
Bivona	FT14KN45NGF123N	FDA UDI	Class II	Active
Bivona	FA14JN60NSD235N	FDA UDI	Class II	Active
Bivona	HT12ES70NNC030N	FDA UDI	Class II	Unknown
Bivona	FT14BN60NGF258N	FDA UDI	Class II	Active
Bivona	FT13IN35NGE221N	FDA UDI	Class II	Active
Bivona	FT13EN35NSF112N	FDA UDI	Class II	Active
Bivona	FT12LN75NSC222N	FDA UDI	Class II	Active
Bivona	FT13BN40NSA331N	FDA UDI	Class II	Unknown
Bivona	SA13LN60NSC315N	FDA UDI	Class II	Active
Bivona	FT14KN40NSE258N	FDA UDI	Class II	Active
Bivona	FT15EN40NGF050N	FDA UDI	Class II	Active
Bivona	FT15DN40NSF011N	FDA UDI	Class II	Active
Bivona	ST12IN90NSC246N	FDA UDI	Class II	Active
Bivona	ST12FN80NSC330N	FDA UDI	Class II	Active
Bivona	FU13HN35NSE295N	FDA UDI	Class II	Active
Bivona	FT13CN35NSE344N	FDA UDI	Class II	Active
Bivona	850160	FDA UDI	Class II	Active
Bivona	FT23FN45NSF031N	FDA UDI	Class II	Active
Bivona	FT20KN60NGF968N	FDA UDI	Class II	Active
Bivona	FT21BN50NGF082N	FDA UDI	Class II	Active
Bivona	FT19EN35NSE072N	FDA UDI	Class II	Active
Bivona	FT19EN40NGF880N	FDA UDI	Class II	Active
Bivona	XT16KS35NSF093N	FDA UDI	Class II	Active
Bivona	XA11JS60NNC112N	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

ICU Medical BV NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

ICU Medical, Inc. has 644 recall records spanning from September 26, 2006, to April 29, 2026, with statuses including completed, open, classified, and terminated. The recalls involve issues such as software malfunctions in monitoring systems (e.g., inaccurate data, unit shutdowns, or lost parameters), hardware defects (e.g., cracked luer connections, occluded stopcocks, or potential leaks in connectors), and performance deviations (e.g., inaccurate compounding volumes or unresponsive user interfaces). Some recalls address specific lot-related concerns, such as particulate contamination or incorrect filter assemblies.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 29, 2026	Z-2312-2026	—	open, classified	Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Apr 29, 2026	Z-2313-2026	—	open, classified	Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Apr 29, 2026	Z-2311-2026	—	open, classified	Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Mar 24, 2026	Z-2210-2026	—	open, classified	Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Dec 19, 2025	Z-1100-2026	—	open, classified	Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Dec 19, 2025	Z-1101-2026	—	open, classified	Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Dec 19, 2025	Z-1111-2026	—	open, classified	Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Dec 15, 2025	Z-1120-2026	—	open, classified	Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Dec 15, 2025	Z-1118-2026	—	open, classified	Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Dec 15, 2025	Z-1119-2026	—	open, classified	Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Dec 15, 2025	Z-1094-2026	—	open, classified	ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
Nov 24, 2025	Z-0965-2026	—	open, classified	For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Nov 24, 2025	Z-0966-2026	—	open, classified	Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Oct 2, 2025	Z-0154-2026	—	open, classified	IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
Sep 8, 2025	Z-0328-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0334-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0362-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0354-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0361-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0338-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0356-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0337-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0329-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0340-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0339-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0349-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0359-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0348-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0332-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0353-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0364-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0358-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0343-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0355-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0333-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0336-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0351-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0331-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0344-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0360-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0346-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0352-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0335-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0365-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0357-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0330-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0350-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0341-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0345-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0342-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0363-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Sep 8, 2025	Z-0347-2026	—	open, classified	Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Aug 6, 2025	Z-2524-2025	—	open, classified	Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Aug 6, 2025	Z-2522-2025	—	open, classified	Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Aug 6, 2025	Z-2525-2025	—	open, classified	Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Aug 6, 2025	Z-2526-2025	—	open, classified	Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Aug 6, 2025	Z-2527-2025	—	open, classified	Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Aug 6, 2025	Z-2523-2025	—	open, classified	Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
Jul 11, 2025	Z-2129-2025	—	open, classified	ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Jun 3, 2025	Z-2116-2025	—	open, classified	Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
May 2, 2025	Z-1763-2025	—	open, classified	Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Apr 22, 2025	Z-1990-2025	—	open, classified	Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Apr 22, 2025	Z-1991-2025	—	open, classified	Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Nov 6, 2024	Z-0652-2025	—	open, classified	Due to finished goods incorrectly packaged and labeled.
Oct 22, 2024	Z-0482-2025	—	open, classified	ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
May 7, 2024	Z-2449-2024	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
May 7, 2024	Z-2448-2024	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
May 7, 2024	Z-2447-2024	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Jul 13, 2023	Z-2430-2023	—	open, classified	Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Mar 22, 2023	Z-1565-2023	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Mar 22, 2023	Z-1567-2023	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Mar 22, 2023	Z-1566-2023	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Mar 22, 2023	Z-1568-2023	—	open, classified	Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Aug 1, 2022	Z-1724-2022	—	open, classified	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Aug 1, 2022	Z-1722-2022	—	open, classified	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Aug 1, 2022	Z-1720-2022	—	open, classified	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Aug 1, 2022	Z-1721-2022	—	open, classified	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Aug 1, 2022	Z-1719-2022	—	open, classified	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Aug 1, 2022	Z-1723-2022	—	open, classified	Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Jun 27, 2022	Z-1681-2022	—	open, classified	Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Jun 27, 2022	Z-1682-2022	—	open, classified	Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
Mar 16, 2021	Z-1586-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1587-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1567-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1584-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1582-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1575-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1565-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1583-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1577-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1578-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1569-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1581-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1572-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1570-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1590-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1576-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1571-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1589-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Mar 16, 2021	Z-1574-2021	—	open, classified	Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.