FDAClass IIOctober 26, 2016

Vein Kit - No Introducer TVS4027-NI(A convenience recall: Sterility Concern

Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room

Why was Vein Kit - No Introducer TVS4027-NI(A convenience recalled?

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers/ Expiration Dates: 60996 8/3/2015 59383 8/20/2015 63706 11/11/2015 65733 11/30/2015 65404 12/26/2015 58253 7/23/2016 58476 8/30/2016 70957 11/6/2016 71370 12/11/2016 72254 1/8/2017 76639 11/19/2017

Product
Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
360 kits
Distribution
Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Recall date
October 26, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls