Windstone Medical Recalls Laparotomy Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 1,528 laparotomy packs 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 medical device where sterility is compromised, posing a risk of infection or harm during surgery. No injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 1,528 Laparotomy Packs (Kit numbers 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A)). 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 products 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 March 2014 to January 2019.
Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or disposal. Consumers are not expected to have these products in their homes, as they are intended for professional medical use.
The recalled product
- Product
- Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,528
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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