Class 3 Device Recall Autovac TL

• Date Initiated by Firm: November 07, 2003
• Date Posted: December 17, 2003
• Recall Status: Terminated on January 20, 2004
• Recall Number: Z-0227-04
• Recall Event ID: 27721
• 510(K)Number: K932093
• Product Classification: Apparatus, Autotransfusion - Product Code CAC
• Product: Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
• Code Information: Model 7924. Lot number 200309 exp. 9/2005
• Recalling Firm/ Manufacturer: Boehringer Laboratories Inc; 500 E Washington St; Norristown PA 19401-5149
• For Additional Information Contact: John Karpowicz; 610-278-0900
• Manufacturer Reason for Recall: Inadequate bond where the tube attaches to the inlet of the bulb.
• FDA Determined Cause: Other
• Action: On 11/7/03, the recalling firm contact each account via visit by field representative. The representative informed the account of the problem and removed the product.
• Quantity in Commerce: 273 units
• Distribution: The product was shipped to hospitals/medical centers in CT, IL, MD, MI, MS, NY, OK, PA, TN, and WA.
• Total Product Life Cycle: TPLC Device Report

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 = CAC and Original Applicant = BOEHRINGER LABORATORIES