The Companion ClearStar Pump System, for enteral feeding.
FDA device recall Z-1142-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- Ross Products Division Abbott Laboratories
- Reason for recall
- The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.
- Action taken
- Consignees were notified by letter dated 6/25/2007. A revised letter was sent 07/26/2007.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 27,814
- Distribution
- Worldwide, including USA and Canada.
- Date initiated
- 2007-06-21
- Date posted
- 2007-08-07
- Date terminated
- 2012-09-26
- Location
- Columbus, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEARSTAR ENTERAL NUTRITION PUMP (K981541) | Frantz Medical Development, Ltd. | 1998-08-13 |