Recall Z-2425-2012 ยท KKX Drape, Surgical, Antimicrobial
Kimberly-Clark Corporation
ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown 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.
| Date | Sep 20, 2012 (initiated Dec 31, 2010) |
| Status | Terminated |
| Reason | The impacted product was not intended for commercial distribution to end users. |
| Root cause | Packaging process control |
| Action | Kimberly-Clark sent a Urgent Medical Recall Notice dated on December 31, 2010. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to: Evaluate their Distribution Facilities Inventory of Ultra Fabric Reinforced surgical Gown to determine if any of impacted product remained within their facility. If present, to discontinue distribution of the impacted product and place in a quarantined location. Complete the attached Distributor Product Withdrawal Response Form and fax it to KC within five days. Destroy the impacted product acc |
| Quantity | 32 cases |
| Distribution | US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.