The Recall Desk
HighFDA (Devices)·Z-0174-2017·Announced 2016-10-26

Windstone Medical Packaging Recalls Dr Mullins Surgical Kits Due to Sterility Risk

Windstone Medical Packaging is recalling 648 Dr Mullins surgical kits because the Medtronic gloves inside 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 a defect (glove splits/holes) compromises sterility, creating a risk of harm (infection) in a high-risk setting (surgery). No injuries or illnesses are reported in the source text, and the agency classification is Class II, which aligns with 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 648 units of the Dr Mullins Kit (kit number PSS1861(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. This defect poses a risk of infection or other adverse health consequences to patients during surgery. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

The recall covers kits with specific lot numbers and expiration dates ranging from February 24, 2015, to August 25, 2017. Healthcare facilities and distributors should stop using these kits immediately and contact Windstone Medical Packaging for instructions on return or disposal.

The recalled product

Product
Dr Mullins Kit, kit number PSS1861(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
648

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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