Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy
FDA device recall Z-2609-2010 · posted 2010-09-28 · Terminated
Recall details
- Recalling firm
- Convatec Inc.
- Reason for recall
- Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.
- Action taken
- Recall notification letters were sent to 46 customers, acute care facilities and durable medical device distributors on July 9, 2010, by Federal Express.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OMP
- Quantity affected
- 1190 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2010-07-09
- Date posted
- 2010-09-28
- Date terminated
- 2011-06-07
- 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 |