Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 unit
FDA device recall Z-2043-2009 · posted 2009-09-09 · Terminated
Recall details
- Recalling firm
- ConvaTec
- Reason for recall
- Labeling: The expiration date does not appear on the product label.
- Action taken
- Urgent Product Recall letters dated 7/29/09, were hand delivered to all direct customers by ConvaTec Sales Reps. Customers were asked to return any unused products to their supplier. The letter also stated that a credit would be issued for the product. Customers are to contact Karen Krenta at the firm's Customer Interaction Center, 1-800-422-8811.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 176 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-07-29
- Date posted
- 2009-09-09
- 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 |