FDA Device recall Z-0376-2022
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
- FDA Device
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548 by Cardinal Health, citing potential for open packaging seals compromising the sterility of the surgical gowns.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0376-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-02 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health |
| Distribution | US |
Product
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Reason
Potential for open packaging seals compromising the sterility of the surgical gowns
Identifiers
| code_info | Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ00…Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (ea) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0376-2022%22
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