FDA Device recall Z-0369-2022
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
- FDA Device
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 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-0369-2022 |
| 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
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Reason
Potential for open packaging seals compromising the sterility of the surgical gowns
Identifiers
| code_info | Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ00…Lot Numbers: 20MFQ001 20MFQ002 20MFQ003 21AFQ001 21BFQ001 21BFQ002 21CFQ001 21CFQ002 21CFQ003 21DFQ001 21DFQ002 21EFQ001 21EFQ002 21FFQ001 21FFQ002 21GFQ001 21GFQ002 21GFQ003 21HFQ001 21JFQ001 UDI: 50885380172500 (cs) 10885380172502 (ea) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0369-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.