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U.S. Department of Health and Human Services

Class 2 Device Recall Convertors Three Quarter Sheet

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  Class 2 Device Recall Convertors Three Quarter Sheet see related information
Date Initiated by Firm January 22, 2003
Date Posted February 25, 2003
Recall Status1 Terminated 3 on December 03, 2003
Recall Number Z-0576-03
Recall Event ID 25475
510(K)Number K002419  
Product Classification unknown device name - Product Code KKX--
Product Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case
Code Information lot number 02LFRW95
Recalling Firm/
Manufacturer		 Allegiance Healthcare Corp.
1500 Waukegan Rd, Bldg K
Mcgaw Park IL 60085-6787
For Additional Information Contact Quality Systems Professional Services
800-292-9332
Manufacturer Reason
for Recall		 The product labeled as sterile had not been through its sterilzation cycle.
FDA Determined
Cause 2		 Other
Action Recalled by letter dated 1/22/03. The accounts were informed of the non-sterile product, requested to examine their inventories for the affected lot, to return any product found for credit and to sub-recall the product from their customers.
Quantity in Commerce 320 drapes
Distribution New Jersey, Georgia, Washington and Florida
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 = KKX-- and Original Applicant = ALLEGIANCE HEALTHCARE COPORATION
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