Southmedic, Inc.
Country not established FDA
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 92 ongoing
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Southmedic, Inc. makes
Southmedic, Inc. manufactures respiratory support devices, including CO₂/O₂ nasal cannulas with varying tube lengths, a funnel adaptor for medical gas connections, and aerosol-generating products like the Oxy2Pro, Vapofil, and Aerosol-T. Their portfolio also includes a vaporizer spacer, a CO₂ monitoring system (OxyArm CO₂), and interlock systems for vaporizers, such as the AnaesLock Three Vaporizer Interlock.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. Their devices are listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Funnel Adaptor Ref K923265
Regimes: 510(k) Registry: 510(k)Oxy2Pro Ref K222511
Regimes: 510(k) Registry: 510(k)Vapofil Ref K945993
Regimes: 510(k) Registry: 510(k)Vapofil Ref K861839
Regimes: 510(k) Registry: 510(k)Aerosol-T Ref K863318
Regimes: 510(k) Registry: 510(k)Vaporizer Spacer Ref K860545
Regimes: 510(k) Registry: 510(k)Oxyarm CO2 Ref K014211
Regimes: 510(k) Registry: 510(k)Smdia-1000 Ref K101953
Regimes: 510(k) Registry: 510(k)Anaeslock Three Vaporizer Interlock HVA003 Ref K843993
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 2
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 27 Oct 2022 Z-0279-2023 Class II Ongoing Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to distribution where it was sold and distributed to customers as non-sterile product labelled as sterile.
2021
- 25 May 2021 Z-2141-2021 Class II Ongoing Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
2017
- 6 Nov 2017 Z-1892-2018 Class II Terminated Scalpels lot contains non-sterile products labeled as sterile.
- 17 Oct 2017 Z-1288-2018 Class II Terminated Potential for loose or missing CO2 diffusers which could result in a non-functioning mask.
2010
- 3 Sep 2010 Z-0988-2011 Unclassified (pre-2012) Terminated Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
Full distribution text
- 3 Sep 2010 Z-0989-2011 Unclassified (pre-2012) Terminated Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
Full distribution text
- 3 Sep 2010 Z-0990-2011 Unclassified (pre-2012) Terminated Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
Full distribution text
- 3 Sep 2010 Z-0988-2011 Unclassified (pre-2012) Terminated Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
2006
- 21 Apr 2006 Z-1189-06 Unclassified (pre-2012) Terminated Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
Full distribution text
- 21 Apr 2006 Z-1190-06 Unclassified (pre-2012) Terminated Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
Full distribution text
- 21 Apr 2006 Z-1189-06 Unclassified (pre-2012) Terminated Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics.
FDA establishments
- Southmedic, Inc. BARRIE Ontario · CA FEI 3001717360
Frequently asked questions
How many devices does Southmedic, Inc. have in the registry?
The registry currently lists 10 devices for Southmedic, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Southmedic, Inc.'s devices?
Among its 10 most recently registered devices, Southmedic, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Southmedic, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Southmedic, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Southmedic, Inc.?
FDA recall records list 9 recalls initiated by Southmedic, Inc., the most recent initiated on 27 Oct 2022. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Southmedic, Inc. in the registry?
The most recently registered devices listed for Southmedic, Inc. include CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),, FUNNEL ADAPTOR, Oxy2Pro and VAPOFIL.
Which FDA establishments are linked to Southmedic, Inc.?
1 FDA establishment is linked to Southmedic, Inc. in the registry; they are listed on the company page.