Date Initiated by Firm |
April 30, 2009 |
Date Posted |
May 26, 2009 |
Recall Status1 |
Terminated 3 on January 07, 2010 |
Recall Number |
Z-1645-2009 |
Recall Event ID |
51959 |
510(K)Number |
K992821
|
Product Classification |
Patient Examination Vinyl 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 GA 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 |
Release of Material/Component prior to receiving 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
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LYZ and Original Applicant = SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD
|