Windstone Medical recalls surgical kits with defective disposable gloves
Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable 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 medical device where sterility is compromised, posing a risk of infection (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 117 Lap/Hyst Pack kits (Kit numbers AMS2539 and AMS2539A) 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 kits.
The gloves may contain splits or holes, which compromises the sterility of the surgical kit. 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 with expiration dates ranging from November 2015 to May 2016.
Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions. Consumers are not expected to have these products in their homes, as they are custom kits for professional medical use.
The recalled product
- Product
- Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 117
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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