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

FDA device recall Z-2836-2011 · posted 2011-07-21 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

Reason for recall

Metal shavings were found within the folded portion of the surgical drape.

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.

Root cause

Process control

Status

Terminated

Product code

KKX

Quantity affected

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.

Date initiated

2011-06-06

Date posted

2011-07-21

Date terminated

2011-10-14

Location

Roswell, GA