Windstone Medical Recalls Shoulder Arthroscopy Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,124 shoulder arthroscopy kits 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 involves a risk-of-harm product (sterile surgical kits) where the defect (compromised sterility) poses a significant risk of infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 1,124 units of Shoulder Arthroscopy Packs. The affected kits include specific kit numbers such as 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. These are convenience custom kits used for general surgery in hospital operating rooms.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit may contain splits or holes. These defects could compromise the sterility of the surgical environment.
The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers lots with expiration dates ranging from August 2013 to January 2018. Healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,124
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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