The Recall Desk
HighFDA (Devices)·Z-0270-2017·Announced 2016-10-26

Windstone Medical Shoulder Packs Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) in a medical device without reported illnesses or injuries, which aligns with the 'High' severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 3,104 units of Shoulder Packs, including kit numbers AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, and PSS1852(A. These convenience custom kits are used for general surgery in hospital operating rooms.

The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kits may contain splits or holes. These defects could compromise the sterility of the gloves, posing a risk to patients during surgical procedures.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers lots with expiration dates ranging from January 5, 2015, to January 23, 2018, as well as one lot with no provided date. Hospitals and healthcare facilities should stop using these specific kits and contact the recalling firm for further instructions.

The recalled product

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
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
3,104

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 150 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

Same hazard · sterility compromise

See all →