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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 648
Distribution
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.
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