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U.S. Department of Health and Human Services

Class 2 Device Recall Embrace Enteral Pump

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 Class 2 Recall
Embrace Enteral Pump
see related information
Date Posted August 08, 2007
Recall Status1 Open
Recall Number Z-1141-2007
Recall Event ID 38222
Premarket Notification
510(K) Number
K031407 
Product Classification Pump, Infusion, Enteral - Product Code LZH
Product Embrace Enteral Pump
Code Information List #55335 & 55336
Recalling Firm/
Manufacturer
Ross Products Division Abbott Laboratories
6480 Busch Blvd
Columbus, Ohio 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
PRODUCTION CONTROLS: Process Control
Action Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.
Quantity in Commerce 9,600 units
Distribution The product was distributed throughout the US.
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 = ROSS PRODUCT DIV. ABBOTT LABORATORIES
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