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U.S. Department of Health and Human Services

Class 2 Device Recall Patrol

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  Class 2 Device Recall Patrol see related information
Date Initiated by Firm May 02, 2007
Date Posted July 10, 2007
Recall Status1 Terminated 3 on March 09, 2012
Recall Number Z-0888-2007
Recall Event ID 37870
510(K)Number K943240  
Product Classification enteral feeding tube - Product Code KNT
Product Patrol enteral pump set with piercing pin, list #520540.
Code Information Lots 45679RY, 46740RY, 46759RY, 46776RY, 47799RY, 47814RY, 47825RY, 47832RY, 47842RY, 48854RY, and 48869RY.
Recalling Firm/
Ross Products Division Abbott Laboratories
6480 Busch Blvd
Columbus OH 43229-1756
For Additional Information Contact Randal P. McKay
Manufacturer Reason
for Recall
The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.
FDA Determined
Cause 2
Action The recalling firm sent a recall letter dated April 27, 2007 to all customers.
Quantity in Commerce 1,042,050 units
Distribution Nationwide
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 = KNT and Original Applicant = ABBOTT LABORATORIES