Enforcement Report - Week of November 14, 2012
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Product Detail
| Product Description | MicroCool Breathable Gown with Towels, X-Larg, X-Long, 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. |
|---|---|
| Recall Number | Z-0258-2013 |
| Classification | Class II |
| Code Info | Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175*** |
| Product Distributed Qty | 933 ((30 units per case) |
| Reason For Recall | Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. |
Event Detail
| Event Id | 63598 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Kimberly-Clark Corporation |
| City | Roswell |
| State | GA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-07-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution |
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