FDA Medical Device Recalls (openFDA)
Boehringer Laboratories Inc: Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
- Recall number
- Z-0227-04
- Recalling firm
- Boehringer Laboratories Inc
- Product
- Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
- Status
- Terminated
- Initiated
- 2003-11-07
- Posted
- 2003-12-17
- Terminated
- 2004-01-20
- Reason
- Inadequate bond where the tube attaches to the inlet of the bulb.
- 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
- 273 units
- Distribution
- The product was shipped to hospitals/medical centers in CT, IL, MD, MI, MS, NY, OK, PA, TN, and WA.
- Lot, serial or model codes
- Model 7924. Lot number 200309 exp. 9/2005
- 510(k) numbers
- ["K932093"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 2518417
- Firm city
- Norristown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28