FDAClass IIOctober 26, 2016

Cardiac Cath Pack recall: Sterility Concern

Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room

Why was Cardiac Cath Pack 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: 67078 11/16/2015 66903 11/26/2015 64343 12/24/2015 68965 9/10/2016 68647 9/18/2016 68147 9/28/2016 70233 10/30/2016 71064 12/7/2016

Product
Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
138 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