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Class 2 Device Recall Patrol |
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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
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Product Classification |
enteral feeding tube - Product Code KNT
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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/ Manufacturer |
Ross Products Division Abbott Laboratories 6480 Busch Blvd Columbus OH 43229-1756
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For Additional Information Contact |
Randal P. McKay 614-624-3688
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = KNT and Original Applicant = ABBOTT LABORATORIES
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