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C. R. Bard, Inc.

United States·US-MF-000018892

Last updated September 17, 2026

What C. R. Bard, Inc. makes

C. R. Bard, Inc. manufactures indwelling urethral catheterization kits, indwelling urethral drainage balloon catheters (both antimicrobial and non-antimicrobial), single-administration urethral drainage catheters, urinary incontinence penis sheaths/ports, polymeric ureteral stents, urethral dilators, and ureteral catheters. Example products include the BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit, Bard Lubricath Foley Catheter, Magic3 Intermittent Catheter with Sure-Grip Sleeve, Bardex Lubricath Foley Catheter Tiemann Model Coude, SureStep Foley Tray System with Bard Lubri-Sil Foley Catheter, SureStep Foley Tray System Bardex IC Complete Care, Silicone Round Drain, Bardia, Bardex Nasopharyngeal Airway, Personal Catheter Intermittent Catheter, Bardia All-Silicone Foley Catheter, and Bard InLay Optima Ureteral Stent with HydroGlide Guidewire.

The company's devices are classified as Class I, Class II, and unclassified (U) devices and are listed in the FDA 510(k) and FDA UDI registries. C. R. Bard, Inc. is based in the United States.

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

Frequently asked questions

What types of medical devices does C. R. Bard, Inc. manufacture?

Where is C. R. Bard, Inc. based?

C. R. Bard, Inc. is based in the United States, as explicitly stated in the SUMMARY section of the device data. The company’s country of origin is listed as US, and no further details about facilities, headquarters location within the US, or operational sites are provided or implied.

In which regulatory registries are C. R. Bard, Inc.'s devices listed?

C. R. Bard, Inc.'s devices are listed in the FDA 510(k) and FDA UDI registries, as stated in the LISTED IN field and reiterated in the SUMMARY. These are the only registries mentioned; no other domestic or international registries are referenced or implied in the provided data.

How are C. R. Bard, Inc.'s devices classified under regulatory frameworks?

C. R. Bard, Inc.'s devices are classified as Class I, Class II, and unclassified (U) devices, as explicitly stated in the DEVICE CLASSES field and confirmed in the SUMMARY. This classification reflects the risk-based categorization used by the FDA, and no device is described as approved, cleared, or certified—only that individual devices may be authorised under these classifications.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 8195, Industrial Boulevard, Covington, United States
Website: No website
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-844-823-5433
PRRC Contact: Elizabeth Gaipa
EUDAMED SRN: US-MF-000018892
FDA FEI Number: 1313046
DUNS Number: 016898496

Catalogue (3458)

Page 59 of 70

Device	Model / Reference	Registries	Class	Status
Bard Microbore Anti-Siphon Nitro Set	K900217	FDA 510(k)	Class II	Active
Phasix ST Mesh with Echo 2 Positioning System	K182008	FDA 510(k)	Class II	Active
Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula	K950700	FDA 510(k)	Class II	Active
Bard Singular Biopsy Forceps	K912214	FDA 510(k)	Class I	Active
Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007	K033814	FDA 510(k)	Class II	Active
Bard Cardiopulmonary Monitoring Lines	K820186	FDA 510(k)	Class II	Active
Bard(r) Syringe Assist Irrigation	K905102	FDA 510(k)	Class II	Active
New Bard Infection Control Urinary Drainage Bag	K844810	FDA 510(k)	Class II	Active
Bard Alfentanil Infuser	K904890	FDA 510(k)	Class II	Active
Bard Er Ureteral Stent With Suture	K022447	FDA 510(k)	Class II	Active
William Harvey H-1700 Adult Blood Oxyg-	K831122	FDA 510(k)	Class II	Active
The Sherlock 3cg Tip Confirmation System (tcs)	K113808	FDA 510(k)	Class II	Active
Catheter Repair Kit With Replacement Connector, Model 5587000	K063446	FDA 510(k)	Class II	Active
Nasal Oxygen Cannula, #017207	K771074	FDA 510(k)	Class I	Active
Bard Plat. Class 3 French Ureteroscopic Flat Wire Stone, Torque Helical Stone Baskets/Grasping Forceps	K961248	FDA 510(k)	Class II	Active
Davol Laparoscopic Dissectors	K920234	FDA 510(k)	Class II	Active
Aspira Peritoneal Drainage System	K110396	FDA 510(k)	Class II	Active
Bard 9fr., 30cc Rediguard And Taperseal Balloons	K973962	FDA 510(k)	Class II	Active
Bard Ems System 6000 E.s.u.	K871435	FDA 510(k)	Class II	Active
Bard(r) Intra Aortic Balloon	K924382	FDA 510(k)	Class II	Active
Davol Nasogastric Sump Tube W/Prevent Filter	K960176	FDA 510(k)	Class II	Active
Vida Ptv Dilataton Catheter	K131002	FDA 510(k)	Class II	Active
Eliminator Balloon Dilator	K940965	FDA 510(k)	Class II	Active
Biolex Impregnated Wound Dressing	K935096	FDA 510(k)	U	Active
Ventrio St Hernia Patch	K101920	FDA 510(k)	Class II	Active
Ventrio Light Hernia Patch With Trm Antimicrobial Coating	K113229	FDA 510(k)	Class II	Active
Usci(r) Hemaflex(tm) Introducer With Coating	K915553	FDA 510(k)	Class II	Active
Alyte Y-Mesh Graft	K101722	FDA 510(k)	Class II	Active
Recovery G2 Filter System - Femoral Delivery Kit, Model Rf-310f; Jugular/Subclavain Delivery Kit, Model Rf-320j	K073090	FDA 510(k)	Class II	Active
U-Balloon Dilation Catheter	K050875	FDA 510(k)	Class II	Active
Site-Rite 5 Ultrasound System	K052517	FDA 510(k)	Class II	Active
Optifix Absorbable Fixation System	K132134	FDA 510(k)	Class II	Active
Bard Tru-Trac Peripheral Balloon Dilatation Catheter	K960517	FDA 510(k)	Class II	Active
Sourcelink	K041576	FDA 510(k)	Class II	Active
Davol Delivery System	K041641	FDA 510(k)	Class II	Active
Catheter, Usci Gruntzig/Balloon	K782071	FDA 510(k)	Class II	Active
Cormed Iii Ambulatory Infusion Pump	K873847	FDA 510(k)	Class II	Active
Bard Ultraview Multiple Band Ligator, Model 00700u	K022434	FDA 510(k)	Class II	Active
Power-Trialysis Short-Term Dialysis Catheter	K133456	FDA 510(k)	Class II	Active
Small Bard Ventralex Patch	K024008	FDA 510(k)	Class II	Active
Inspiron Manifold (double)	K772294	FDA 510(k)	Class II	Active
Oxygen Connecting Tube #017205	K771075	FDA 510(k)	Class I	Active
Bard Short Rigid Ureteroscope	K900813	FDA 510(k)	Class II	Active
Advanset	K771261	FDA 510(k)	Class II	Active
Pelvilace Transobturator Biourethral Support System (pelvilace To System)	K042949	FDA 510(k)	Class II	Active
Bard Eska Jonas Silicone-Silver Penile Prosthesis	K864040	FDA 510(k)	Class II	Active
Sleek Otw Pta Catheter	K130786	FDA 510(k)	Class II	Active
Recovery Cone Removal System	K152136	FDA 510(k)	Class II	Active
Bard Luminexx Biliary Stent	K003793	FDA 510(k)	Class II	Active
Airguard Valved Introducer	K042036	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Becton Dickinson Ireland Limited IE

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.

There are 167 recall records for C. R. Bard, Inc., with the earliest initiated on September 23, 2008, and the most recent initiated on April 23, 2026. The statuses of these recalls include completed, open, classified, and terminated. The reasons given for the recalls include labeling discrepancies, potential product defects such as obstructed lumens or leaks, package seal issues, incorrect unit or case labeling, and concerns related to sterility barriers or material composition, as stated in the records.

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 23, 2026	Z-2226-2026	—	open, classified	Due to stain present on the surface of affected foley catheters.
Nov 6, 2025	Z-0907-2026	—	open, classified	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Nov 6, 2025	Z-0906-2026	—	open, classified	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Nov 6, 2025	Z-0908-2026	—	open, classified	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Nov 6, 2025	Z-0905-2026	—	open, classified	Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Jul 17, 2025	Z-2591-2025	—	open, classified	Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Jul 17, 2025	Z-2590-2025	—	open, classified	Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Jul 17, 2025	Z-2589-2025	—	open, classified	Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Jun 18, 2025	Z-2462-2025	—	open, classified	Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Jun 3, 2025	Z-2076-2025	—	open, classified	Cather packaging may contain the incorrect French size.
Jun 3, 2025	Z-2075-2025	—	open, classified	Cather packaging may contain the incorrect French size.
Jun 3, 2025	Z-2074-2025	—	open, classified	Cather packaging may contain the incorrect French size.
Apr 17, 2025	Z-1756-2025	—	open, classified	Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Apr 17, 2025	Z-1757-2025	—	open, classified	Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Apr 17, 2025	Z-1758-2025	—	open, classified	Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Apr 17, 2025	Z-1755-2025	—	open, classified	Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Apr 17, 2025	Z-1759-2025	—	open, classified	Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
May 9, 2024	Z-2154-2024	—	open, classified	Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Dec 20, 2023	Z-0794-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0799-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0791-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0800-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0801-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0806-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0797-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0790-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0798-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0792-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0795-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0796-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0803-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0804-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0802-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0793-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Dec 20, 2023	Z-0805-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
Nov 15, 2023	Z-0554-2024	—	open, classified	BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
Apr 20, 2023	Z-1699-2023	—	open, classified	Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Apr 20, 2023	Z-1700-2023	—	open, classified	Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Apr 20, 2023	Z-1698-2023	—	open, classified	Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
Apr 20, 2023	Z-1701-2023	—	open, classified	Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
May 19, 2022	Z-1293-2022	—	open, classified	Complaints relating to urine output measurement accuracy.
Jan 27, 2022	Z-0666-2022	—	open, classified	There is a potential to leak from the catheter where it connects to the drain bag
Jan 27, 2022	Z-0667-2022	—	open, classified	There is a potential to leak from the catheter where it connects to the drain bag
Aug 5, 2021	Z-2530-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2529-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2534-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2521-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2532-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2528-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2526-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2536-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2525-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2541-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2523-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2531-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2522-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2524-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2535-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2538-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2540-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2537-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2533-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2539-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Z-2527-2021	—	open, classified	There is potential for packaging defects that may impact the sterile barrier.
Jan 11, 2021	Z-1431-2021	—	terminated	The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Apr 15, 2020	Z-1970-2020	—	terminated	There is potential for a white paper-type residue attached to the catheter.
Jan 13, 2020	Z-1219-2020	—	terminated	Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be confirmed with other means, such as a new IAP system of the same kind or by choosing other diagnostic means such as but not limited to alternative systems, such as open IAP measurement options or exchanging the tubing system, which does not require invasive maneuvers.
Feb 27, 2018	Z-1357-2018	—	terminated	BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Feb 27, 2018	Z-1355-2018	—	terminated	BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Feb 27, 2018	Z-1356-2018	—	terminated	BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Feb 27, 2018	Z-1354-2018	—	terminated	BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Dec 13, 2017	Z-2064-2018	—	terminated	Foley Catheter with Incorrect Retainer Cap Print
Nov 10, 2017	Z-0565-2018	—	terminated	BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
Nov 10, 2017	Z-2243-2018	—	open, classified	Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
Oct 16, 2017	Z-0271-2018	—	terminated	Hydrogel peeling from the pads.
Sep 29, 2017	Z-0488-2018	—	terminated	The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
Sep 14, 2017	Z-1309-2018	—	terminated	Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Sep 14, 2017	Z-1307-2018	—	terminated	Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Sep 14, 2017	Z-1308-2018	—	terminated	Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
Jul 28, 2017	Z-3226-2017	—	terminated	Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
Jun 2, 2017	Z-2872-2017	—	terminated	Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
Jun 2, 2017	Z-0590-2018	—	open, classified	Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.
Mar 31, 2017	Z-3042-2017	—	terminated	Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continued use is in excess of 2000 system hours without preventive maintenance.
Mar 9, 2017	Z-1871-2017	—	completed	Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
Dec 9, 2016	Z-0267-2018	—	terminated	Activity and quantity of seeds sent in shipments were incorrect.
Oct 13, 2016	Z-0404-2017	—	terminated	Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Oct 13, 2016	Z-0403-2017	—	terminated	Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Oct 13, 2016	Z-0405-2017	—	terminated	Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Oct 13, 2016	Z-0406-2017	—	terminated	Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
Oct 12, 2016	Z-0585-2017	—	terminated	Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.
Oct 12, 2016	Z-0363-2017	—	terminated	Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Oct 5, 2016	Z-0600-2017	—	terminated	Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
Aug 3, 2016	Z-0738-2017	—	terminated	Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Aug 3, 2016	Z-0737-2017	—	terminated	Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Aug 3, 2016	Z-0735-2017	—	terminated	Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Aug 3, 2016	Z-0736-2017	—	terminated	Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Jul 11, 2016	Z-2830-2016	—	terminated	During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Jul 11, 2016	Z-0967-2017	—	terminated	The product contained a latex catheter instead of a silicone catheter.
Jul 11, 2016	Z-2831-2016	—	terminated	During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Jun 30, 2016	Z-2345-2016	—	terminated	An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

C.r. Bard, Inc. MADISON, GA · US FEI 3006082230