FDAClass IIOctober 26, 2016

Dr. Newman Surgical Procedure Pack recall: Sterility Concern

Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room

Why was Dr. Newman Surgical Procedure 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: 58460 7/10/2015 60260 7/18/2015 61708 10/14/2015 65115 11/17/2015 61937 11/29/2015 64687 1/12/2016 68445 3/17/2016 66915 7/5/2016 57957 7/21/2016 67620 9/29/2016 70297 10/26/2016 73096 11/12/2016 72508 11/21/2016 73565 12/20/2016 74851 1/23/2017 75802 4/30/2017 79176 5/5/2017 79475 5/26/2017 79793 6/27/2017

Product
Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
666 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