Z-0227-04

Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons...

Name: Z-0227-04 Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons...
Creator: Boehringer Laboratories Inc
Published: 2003-11-07
License: https://open.fda.gov/license/

Boehringer Laboratories, LLC / initiated 2003-11-07 / Terminated

FDA source

Boehringer Laboratories Inc began a recall of Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units on 2003-11-07. The reason FDA records is "Inadequate bond where the tube attaches to the inlet of the bulb". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0227-04
Status: Terminated
Initiated: 2003-11-07
Posted: 2003-12-17
Terminated: 2004-01-20
Recalling firm: Boehringer Laboratories, LLC
Product: Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Inadequate bond where the tube attaches to the inlet of the bulb.
FDA root 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.
Product codes and lots: Model 7924. Lot number 200309 exp. 9/2005

Product code CAC

K932093Class IIAutovac Closed Wound Autotransfusion System,7920 SBoehringer Laboratories / cleared 1994-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)