ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical

FDA device recall Z-2425-2012 · posted 2012-09-20 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

Reason for recall

The impacted product was not intended for commercial distribution to end users.

Action taken

Kimberly-Clark sent a Urgent Medical Recall Notice dated on December 31, 2010. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to: Evaluate their Distribution Facilities Inventory of Ultra Fabric Reinforced surgical Gown to determine if any of impacted product remained within their facility. If present, to discontinue distribution of the impacted product and place in a quarantined location. Complete the attached Distributor Product Withdrawal Response Form and fax it to KC within five days. Destroy the impacted product according to their facility procedures. And to review their distribution records to identify all customers who were shipped any of the impacted products. Notify each of their customers who were shipped any of the impacted products by sending them a copy of the attached Customer Letter with the Customer Withdrawal Response Form. A minimum of three (3) attempts to contact each non-responding customer within interval of approximately four to six weeks will be performed. Once all customers who were notified have responded or after approximately four weeks after the third attempt to contact the last non-responder, a recall Termination will be initiated If your Kimberly-Clark Representative has not already contacted you, please contact the Ultra Fabric Reinforce surgical Gown Coordinator at (770) - 587-7700.

Root cause

Packaging process control

Status

Terminated

Product code

KKX

Quantity affected

32 cases

Distribution

US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.

Date initiated

2010-12-31

Date posted

2012-09-20

Date terminated

2012-11-01

Location

Roswell, GA