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. |
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 and Original Applicant = FRANTZ MEDICAL DEVELOPMENT, LTD.
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