Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
FDA Recall Z-0227-04 · Posted 2003-12-17
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Recalling FirmBoehringer Laboratories Inc
Recall StatusTerminated
Product CodeCAC
Date Initiated2003-11-07
Date Terminated2004-01-20
Product Quantity273 units
Reason for Recall
Inadequate bond where the tube attaches to the inlet of the bulb.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was shipped to hospitals/medical centers in CT, IL, MD, MI, MS, NY, OK, PA, TN, and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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