Date Initiated by Firm |
November 12, 2004 |
Date Posted |
December 21, 2004 |
Recall Status1 |
Terminated 3 on February 21, 2007 |
Recall Number |
Z-0335-05 |
Recall Event ID |
30433 |
510(K)Number |
K915110
|
Product Classification |
unknown device name - Product Code LNO
|
Product |
20 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (list #50738).
|
Code Information |
Lots: 02562GZ00, 04658GZ00, 07738GZ00, 12917GZ00, 15061GZ00, 89905GZ00, 96435GZ00. |
Recalling Firm/ Manufacturer |
Abbott Laboratories 6550 Singletree Dr Columbus OH 43229-1119
|
For Additional Information Contact |
Randal P. McKay 614-624-3688
|
Manufacturer Reason for Recall |
Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed.
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm notified customers by letter, dated 11/12/04. |
Quantity in Commerce |
822 gastrostomy kits. |
Distribution |
The product was distributed throughout the United States and to foreign consignees located in Australia, Korea, Thailand, Venezuela, and Puerto Rico. |
|
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 = LNO and Original Applicant = ABBOTT LABORATORIES
|