Windstone Medical Recalls Laparoscopy Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 50 laparoscopy kits because the disposable gloves included may contain 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 (splits/holes) compromises sterility, creating a risk of harm (infection) during surgery. As no specific injuries or illnesses are reported in the source text, the hazard is theoretical, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 50 units of Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B). These are convenience custom kits used for general surgery in hospital operating rooms. The recall is limited to specific lot numbers and expiration dates: 57847 (10/1/2014), 59048 (10/13/2014), 62496 (10/19/2014), 65226 (10/26/2014), and 65787 (10/18/2014).
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 gloves, posing a risk to patients during surgical procedures.
The affected kits were distributed nationwide to facilities in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed above and stop using the affected kits immediately.
The recalled product
- Product
- Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 50
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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