Recall Z-2836-2011 ยท KKX Drape, Surgical, Antimicrobial
Kimberly-Clark Corporation
Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.
| Date | Jul 21, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | Metal shavings were found within the folded portion of the surgical drape. |
| Root cause | Process control |
| Action | Kimberly-Clark Corporation sent an "Urgent: Voluntary Product Recall" letter dated June 6, 2011 to all affected customers and a subsequent letter dated June 22, 2011. The letter notified them of the recall and provided recommendations. They were instructed to evaluate their facilities unused inventory of the affected drapes to determine if any of the impacted product lots remain with their facility. If present, they were to quarantine and discontinue use. A Customer Product Recall Response Form was included to be completed and faxed to KC. They will be contacted by a representative regardin |
| Quantity | 223 cases (300 units per case) |
| Distribution | Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.