RecallRadar

FDA Device recall Z-0270-2017

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits…

On 2016-10-26 the FDA classified a Class II recall of Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits… by Windstone Medical Packaging, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0270-2017
ClassificationClass II
Statusterminated
Initiated2015-04-22
Published2016-10-26
Last updated2026-09-13 11:54 UTC
CompanyWindstone Medical Packaging
DistributionUS

Product

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room

Reason

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.

Identifiers

code_info
Lot Number/ Expiration Date: 61069 1/5/2015 57470 1/15/2015 64162 1/20/2015 66792 1/31/2015 61312 2/27/2015 663…Lot Number/ Expiration Date: 61069 1/5/2015 57470 1/15/2015 64162 1/20/2015 66792 1/31/2015 61312 2/27/2015 66392 2/27/2015 59327 4/24/2015 60099 7/15/2015 61872 7/26/2015 60277 8/24/2015 60278 8/24/2015 61393 9/7/2015 63201 9/15/2015 61394 10/14/2015 62762 11/3/2015 61940 11/17/2015 62155 11/23/2015 64557 11/27/2015 61280 11/27/2015 61279 11/28/2015 61392 11/30/2015 66184 12/24/2015 65278 12/27/2015 63178 1/3/2016 63994 1/13/2016 64601 1/13/2016 64643 1/17/2016 63782 1/23/2016 63783 1/23/2016 73045 1/29/2016 69613 2/19/2016 69677 4/9/2016 70513 4/11/2016 76391 4/13/2016 74109 4/24/2016 57074 5/25/2016 76644 5/30/2016 57513 6/20/2016 71983 7/15/2016 67297 7/20/2016 67764 7/20/2016 58232 7/24/2016 58465 7/25/2016 77327 7/26/2016 77744 7/30/2016 78161 7/30/2016 65887 8/1/2016 67940 8/23/2016 68760 9/22/2016 70301 9/22/2016 70693 10/7/2016 69712 10/26/2016 68631 10/31/2016 71525 12/18/2016 71460 1/3/2017 72471 1/10/2017 72320 1/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0270-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.