| Date Initiated by Firm | June 21, 2007 |
|---|
| Date Posted | August 08, 2007 |
|---|
| Recall Status1 |
Terminated 3 on September 20, 2012 |
| Recall Number | Z-1141-2007 |
|---|
| Recall Event ID |
38222 |
| 510(K)Number | K031407 |
|---|
| Product Classification |
Enteral Pump - Product Code LZH
|
| Product | Embrace Enteral Pump |
|---|
| Code Information |
List #55335 & 55336 |
Recalling Firm/
Manufacturer |
Ross Products Division Abbott Laboratories
6480 Busch Blvd
Columbus OH 43229-1756
|
| For Additional Information Contact | Mr. Randal McKay
614-624-3688 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Equipment maintenance |
|---|
| Action | Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007. |
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| Quantity in Commerce | 9,600 units |
|---|
| Distribution | The product was distributed throughout the US. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LZH
|
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