Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units
FDA device recall Z-0227-04 · posted 2003-12-17 · Terminated
Recall details
- Recalling firm
- Boehringer Laboratories Inc
- Reason for recall
- Inadequate bond where the tube attaches to the inlet of the bulb.
- Action taken
- 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
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 273 units
- Distribution
- The product was shipped to hospitals/medical centers in CT, IL, MD, MI, MS, NY, OK, PA, TN, and WA.
- Date initiated
- 2003-11-07
- Date posted
- 2003-12-17
- Date terminated
- 2004-01-20
- Location
- Norristown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S (K932093) | Boehringer Laboratories | 1994-07-06 |