Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For M

FDA device recall Z-1645-2009 · posted 2009-05-26 · Terminated

Recall details

Recalling firm

Kimberly-Clark Corporation

Reason for recall

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

Action taken

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.

Root cause

Release of Material/Component prior to receiving test results

Status

Terminated

Product code

LYZ

Quantity affected

920 cases/10 boxes per case

Distribution

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

Date initiated

2009-04-30

Date posted

2009-05-26

Date terminated

2010-01-07

Location

Roswell, GA

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