Embrace Enteral Pump
FDA device recall Z-1141-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Ross Products Division Abbott Laboratories
- Reason for recall
- Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.
- Action taken
- Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- LZH
- Quantity affected
- 9,600 units
- Distribution
- The product was distributed throughout the US.
- Date initiated
- 2007-06-21
- Date posted
- 2007-08-08
- Date terminated
- 2012-09-20
- Location
- Columbus, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROSS EMBRACE ENTERAL PUMP (K031407) | Ross Product Div. Abbott Laboratories | 2003-05-20 |