Windstone Medical Recalls Upper Extremity Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 108 Upper Extremity Packs because the included Medtronic gloves 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 is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 108 Upper Extremity Packs, identified by kit numbers AMS2536 and AMS2536(A). These convenience custom kits are 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 kits, which 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 for the recalled units are 62892 (3/18/2014), 61288 (3/30/2014), 66302 (11/8/2015), 64646 (11/30/2015), 68734 (12/19/2015), and 68513 (12/31/2015).
Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 108
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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