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U.S. Department of Health and Human Services

Class 3 Device Recall Autovac TL

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 Class 3 Device Recall Autovac TLsee related information
Date Initiated by FirmNovember 07, 2003
Date PostedDecember 17, 2003
Recall Status1 Terminated 3 on January 20, 2004
Recall NumberZ-0227-04
Recall Event ID 27721
510(K)NumberK932093 
Product Classification Apparatus, Autotransfusion - Product Code CAC
ProductAutovac 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
FEI Number 2518417
Recalling Firm/
Manufacturer		 Boehringer Laboratories Inc
500 E Washington St
Norristown PA 19401-5149
For Additional Information ContactJohn Karpowicz
610-278-0900
Manufacturer Reason
for Recall		Inadequate bond where the tube attaches to the inlet of the bulb.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce273 units
DistributionThe product was shipped to hospitals/medical centers in CT, IL, MD, MI, MS, NY, OK, PA, TN, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CAC
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