ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free
FDA device recall Z-1814-2009 · posted 2009-09-29 · Terminated
Recall details
- Recalling firm
- ConvaTec
- Reason for recall
- Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
- Action taken
- Recall notification letters were hand delivered on July 13, 2009 to all direct customers (tier 1) by ConvaTec reps. Letters were provided to all direct customers so that they could notify all customers that received the product.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 764
- Distribution
- Nationwide distribution and ConvaTec sales rep in the UK and France.
- Date initiated
- 2009-07-13
- Date posted
- 2009-09-29
- Date terminated
- 2009-10-02
- Location
- Skillman, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (K061788) | Boehringer Laboratories | 2006-07-11 |