| Date Initiated by Firm | June 21, 2007 |
|---|
| Date Posted | August 07, 2007 |
|---|
| Recall Status1 |
Terminated 3 on September 26, 2012 |
| Recall Number | Z-1142-2007 |
|---|
| Recall Event ID |
38223 |
| 510(K)Number | K981541 |
|---|
| Product Classification |
enteral pump - Product Code LZH
|
| Product | The Companion ClearStar Pump System, for enteral feeding. |
|---|
| Code Information |
List #55238 & 55239 |
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 | The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product. |
|---|
FDA Determined
Cause 2 | Equipment maintenance |
|---|
| Action | Consignees were notified by letter dated 6/25/2007. A revised letter was sent 07/26/2007. |
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| Quantity in Commerce | 27,814 |
|---|
| Distribution | Worldwide, including USA and Canada. |
|---|
| 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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