Windstone Medical Recalls Podiatry Kits Due to Sterility Compromise
Windstone Medical Packaging is recalling 545 podiatry kits because disposable 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 risk-of-harm product (sterility compromise in surgical kits) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 545 units of Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C. 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 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 recall covers specific lot numbers and expiration dates ranging from February 2015 to July 2017.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or disposal. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 545
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.
See all 150 products in this recall →Related recalls
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