Home › Device types › PXC
Personal Protection Kit
FDA product code PXC · Class 1 · General Hospital
47
Registered devices
1
Adverse events
1
Recalls
0
510(k) clearances
Devices with this code
Regard™ — ROI CPS, LLCRegard™ — ROI CPS, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.Regard™ — ROI CPS, LLCSTRADIS HEALTHCARE — STRADIS MEDICAL, LLCNAR — NORTH AMERICAN RESCUE, LLCRegard™ — ROI CPS, LLCRegard™ — ROI CPS, LLCAFFLINK — Bosma EnterprisesSTRADIS HEALTHCARE — STRADIS MEDICAL, LLCRegard™ — ROI CPS, LLCRegard™ — ROI CPS, LLCStradis Medical, LLC. — STRADIS MEDICAL LLCMedSource Gloves — MEDSOURCE INTERNATIONAL LLCMedSource Gloves — MEDSOURCE INTERNATIONAL LLCAFFLINK — Bosma EnterprisesRegard™ — ROI CPS, LLCBosma Enterprises — Bosma EnterprisesStradis Medical, LLC. — STRADIS MEDICAL LLCBosma Enterprises — Bosma EnterprisesMedSource Gloves — MEDSOURCE INTERNATIONAL LLCRegard™ — ROI CPS, LLCRegard™ — ROI CPS, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
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