RecallRadar

FDA Device recall Z-0226-2017

Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room

On 2016-10-26 the FDA classified a Class II recall of Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room 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-0226-2017
ClassificationClass II
Statusterminated
Initiated2015-04-22
Published2016-10-26
Last updated2026-09-13 11:54 UTC
CompanyWindstone Medical Packaging
DistributionUS

Product

Lithotomy Pack, Kit number AMS2333 and AMS2333(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 numbers/Expiration dates: 61276 3/4/2014 61277 3/10/2014 62761 11/15/2015 64641 11/30/2015 65276 11/30/2015…Lot numbers/Expiration dates: 61276 3/4/2014 61277 3/10/2014 62761 11/15/2015 64641 11/30/2015 65276 11/30/2015 69772 12/3/2015 71457 12/3/2015 68312 12/5/2015 69392 12/17/2015 71152 12/17/2015 68629 12/25/2015 64905 12/27/2015

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-0226-2017%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.