Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.
This recall has been terminated (originally issued July 21, 2011).
- Company
- Kimberly-Clark Corporation
- Recall Initiated
- June 6, 2011
- Posted
- July 21, 2011
- Terminated
- October 14, 2011
- Recall Number
- Z-2836-2011
- Quantity
- 223 cases (300 units per case)
- Firm Location
- Roswell, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Metal shavings were found within the folded portion of the surgical drape.
Distribution
Nationwide (USA) distribution, including the states of CA, FL, GA, IA, IL, MO, NC, NY, OH, TN, TX, VA and WI.
Lot / Code Info
Product Code: 79147 Lot numbers: AC1080052, AC1093104, AC1094061, AC1098193, AC1099073, AC1099213, AC1099074, AC1100074, AC1105054, AC 1124031, AC1124092, AC1126173, AC 1127013, AC 1128153, AC1129031, AC1129062, AC1130011, AC1130092, AC1082042, AC1089111, AC1102021 AC1102141, AC1103031, AC1104101, AC1106103, AC1106164, AC1107084, AC1121184, AC1122071, AC1122192, AC1123012, AC1125111, AC1131082, AC1131092, AC1131151, AC1134133.
Root Cause
Process control
Action Taken
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 regarding the return and replenishment of the product. If the product was further distributed, the consignee was advised to contact the end user, make them aware of the recall and to retrieve any of the affected product in inventory. For additional information please contact Kimberly-Clark Regulatory Affairs at 770-587-7400.