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U.S. Department of Health and Human Services

Class 2 Device Recall Kimberly Clark Synthetic PowderFree Vinyl Exam Gloves

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 Class 2 Recall
Kimberly Clark Synthetic PowderFree Vinyl Exam Gloves
see related information
Date Posted May 26, 2009
Recall Status1 Terminated on January 07, 2010
Recall Number Z-1645-2009
Recall Event ID 51959
Premarket Notification
510(K) Number
K992821 
Product Classification Vinyl Patient Examination Glove - Product Code LYZ
Product 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
Code Information Lot number SG8326661.
Recalling Firm/
Manufacturer
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell, Georgia 30076
For Additional Information Contact Thomas Kozma, PhD
770-587-8000
Manufacturer Reason
for Recall
The product may contain defects/holes reducing the product's effectiveness as a barrier.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to Test Results
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.
Quantity in Commerce 920 cases/10 boxes per case
Distribution Nationwide Distribution -- USA including states of CT, MA, MD, NJ, and NY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LYZ and Original Applicant = SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
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