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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 Device Recall Embrace Enteral Pump see related information
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.
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 and Original Applicant = ROSS PRODUCT DIV. ABBOTT LABORATORIES
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