The Recall Desk
HighFDA (Devices)·Z-0236-2017·Announced 2016-10-26

Windstone Medical Packaging Recalls Surgical Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 64 surgical kits because Medtronic gloves inside may have splits or holes, compromising 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 a defect (splits/holes in gloves) compromises sterility, posing a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 64 Major Pack kits (Kit Numbers PSS3516 and PSS3516A) 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 specific lot numbers and expiration dates involved are 74830 (5/31/2017) and 79119 (11/11/2017).

Hospitals and healthcare facilities should check their inventory for these specific kit numbers and lot dates. If found, the kits should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
Major Pack, Kit Number PSS3516 and PSS3516(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
64

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 Numbers/ Expiration Dates: 74830 5/31/2017 79119 11/11/2017

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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