Class 2 Device Recall Convertors Three Quarter Sheet

• Date Initiated by Firm: January 22, 2003
• Date Posted: February 25, 2003
• Recall Status: Terminated 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: 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--