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Class 2 Device Recall jejunostomy kits |
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Date Initiated by Firm |
November 12, 2004 |
Date Posted |
December 21, 2004 |
Recall Status1 |
Terminated 3 on February 21, 2007 |
Recall Number |
Z-0328-05 |
Recall Event ID |
30433 |
510(K)Number |
K925102
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Product Classification |
unknown device name - Product Code LNO
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Product |
18 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener Set (List #51174) Assorted Single Use Sterile Jejunostomy Kits. |
Code Information |
Lots: 01528GZ00, 04666GZ00, 08764GZ00, 10840GZ00, 12921GZ00, 14003GZ00, 14019GZ00, 15080GZ00, 17178GZ00, 82485GZ00, 86727GZ00, 88827GZ00, 91053GZ00, 91157GZ00, 94377GZ00, 96466GZ00 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 6550 Singletree Dr Columbus OH 43229-1119
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For Additional Information Contact |
Randal P. McKay 614-624-3688
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Manufacturer Reason for Recall |
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm notified customers by letter, dated 11/12/04. |
Quantity in Commerce |
3247 jejunostomy kits. |
Distribution |
The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico. |
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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 = LNO and Original Applicant = ABBOTT LABORATORIES
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