Class 2 Device Recall gastrostomy kits

• Date Initiated by Firm: November 12, 2004
• Date Posted: December 21, 2004
• Recall Status: Terminated 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.
• FEI Number: 1527460
• 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: 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