The Recall Desk
HighFDA (Devices)·Z-0182-2017·Announced 2016-10-26

Windstone Medical ENT Surgery Kits Recalled for Sterility Compromise

Windstone Medical Packaging is recalling 1,795 ENT surgery kits because the disposable gloves included may have 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 involves a medical device where sterility is compromised, posing a risk of infection (risk-of-harm product), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,795 units of ENT Tray, Kit number AMS1195(A). These are convenience custom kits used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom AMS kit.

The gloves may contain splits or holes that compromise sterility. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers and expiration dates ranging from July 2015 to October 2017.

Hospitals and surgical facilities should stop using these kits and contact the manufacturer for instructions on return or replacement. Patients who have already had surgery using these kits should contact their healthcare provider if they have concerns about sterility.

The recalled product

Product
ENT Tray, Kit number AMS1195(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
1,795

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.

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Same hazard · sterility compromise

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