FDA Recall Terminated

Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Distributed by Kimberly Clark LLC, Roswell, GA

Recall: Z-1645-2009 · Initiated April 30, 2009

Recall

Recall Number: Z-1645-2009
Event Number: 51959
Firm: Kimberly-Clark Corporation
FEI Number: 1000015879
Product Code: LYZ
Status: Terminated
Root Cause: Release of Material/Component prior to receiving test results
Initiated: April 30, 2009
Posted: May 26, 2009
Terminated: January 7, 2010
Address: 1400 Holcomb Bridge Rd, Roswell, GA, 30076

Description

Reason

The product may contain defects/holes reducing the product's effectiveness as a barrier.

Action

Consignees were contacted by an Urgent: Medical Recall letter on/about 4/30/2009. The letter instructs the Distributor to extend the recall to the end-user level by notifying each of their customers of the recall via a Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. Distributors were instructed to cease further shipment of the product and to physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. The customer was instructed to immediately cease further use of the gloves and physically quarantine the product and fax the completed Response Sheet within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, KC will arrange pick-up of the affected products and deliver it to a quarantine location at the contracted warehouse.

Distribution

Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY.

Quantity

920 cases/10 boxes per case