FDA Device recall Z-0257-2013
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical pati…
- FDA Device
- Class II
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class II recall of ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical pati… by Kimberly Clark, citing package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0257-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-05 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Kimberly Clark |
| Distribution | US |
Product
ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Reason
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Identifiers
| code_info | Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146*** |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0257-2013%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.