Class 2 Device Recall KimberlyClark, Three Quarter Drape

• Date Initiated by Firm: June 06, 2011
• Date Posted: July 21, 2011
• Recall Status: Terminated on October 14, 2011
• Recall Number: Z-2836-2011
• Recall Event ID: 59161
• Product Classification: Surgical Drape - Product Code KKX
• Product: Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.
• Code Information: 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.
• FEI Number: 1000015879
• Recalling Firm/ Manufacturer: Kimberly-Clark Corporation; 1400 Holcomb Bridge Rd; Roswell GA 30076
• For Additional Information Contact: Thomas Kozma, PhD; 770-587-7835
• Manufacturer Reason for Recall: Metal shavings were found within the folded portion of the surgical drape.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.