FDAClass IIOctober 26, 2016

Minor Lithotomy Pack recall: Sterility Concern

Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room

Why was Minor Lithotomy 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: 66523 1/31/2014 61660 2/2/2014 61505 2/24/2014 60540 3/30/2014 67197 9/10/2014 65055 9/30/2014 58208 7/5/2016 68949 9/12/2016 71055 12/27/2016

Product
Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
114 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