| Class 2 Device Recall Patrol |  |
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
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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 |
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 | 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
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