Z-2836-2011

Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape

Name: Z-2836-2011 Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape
Creator: Kimberly-Clark Corporation
Published: 2011-06-06
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2011-06-06 / Terminated / root cause: manufacturing process

FDA source

Kimberly-Clark Corporation began a recall of Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape on 2011-06-06. The reason FDA records is "Metal shavings were found within the folded portion of the surgical drape". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2836-2011
Status: Terminated
Initiated: 2011-06-06
Posted: 2011-07-21
Terminated: 2011-10-14
Recalling firm: Kimberly-Clark Corporation
Product: Kimberly-Clark, Three Quarter Drape, Non sterile/Disposable, Surgical drape.
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Metal shavings were found within the folded portion of the surgical drape.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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.

Product code KKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)