The Recall Desk
HighFDA (Devices)·Z-0162-2017·Announced 2016-10-26

Windstone Medical Recalls Cath Packs Due to Potential Sterility Compromise

Windstone Medical Packaging is recalling 246 Cath Pack kits because the included Medtronic gloves 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 risk-of-harm product (sterile surgical kit) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical risk without confirmed adverse events.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 246 units of the Cath Pack, kit number AMS4283. 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, which are included in the custom AMS kit.

The gloves may contain splits or holes that compromise sterility. The affected lots are 77875 (expiration 7/30/2016), 78282 (expiration 7/30/2016), and 78570 (expiration 9/28/2017). The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on return or disposal. No illnesses or injuries have been reported in the source text.

The recalled product

Product
Cath Pack, kit number AMS4283 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
246

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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