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U.S. Department of Health and Human Services

Class 2 Device Recall The Companion ClearStar Pump System

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 Class 2 Recall
The Companion ClearStar Pump System
see related information
Date Posted August 07, 2007
Recall Status1 Open
Recall Number Z-1142-2007
Recall Event ID 38223
Premarket Notification
510(K) Number
Product Classification Pump, Infusion, Enteral - Product Code LZH
Product The Companion ClearStar Pump System, for enteral feeding.
Code Information List #55238 & 55239
Recalling Firm/
Ross Products Division Abbott Laboratories
6480 Busch Blvd
Columbus, Ohio 43229-1756
For Additional Information Contact Mr. Randal McKay
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
DESIGN: Device Design
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = FRANTZ MEDICAL DEVELOPMENT, LTD.