Device Recall ULTRA Fabric Reinforced Surgical Gown 의 리콜

Recall

62577

Class 3

Z-2425-2012

2010-12-31

2012-09-20

Terminated

United States

2012-11-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111080

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

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.