The Recall Desk
HighFDA (Devices)·Z-0203-2017·Announced 2016-10-26

Windstone Medical Recalls Hall SAP Surgical Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 30 Hall SAP surgical 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 (sterility compromise in surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 30 units of Hall SAP, Kit number SRK1031(A, which 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 lot number is 57039 with an expiration date of 5/21/2016. These kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions on how to return or dispose of the product.

The recalled product

Product
Hall SAP, Kit number SRK1031(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
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number/Expiration Date: 57039 5/21/2016

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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