Windstone ENT Surgical Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 123 ENT surgical 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 injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 123 ENT Pack kits (kit numbers AMS2727, AMS3237A, and AMS4214) used for general surgery in hospital operating rooms. The recall is due to the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom kits, which 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 specific lot numbers and expiration dates for the recalled units are 63064 (11/3/2015), 64818 (1/4/2016), 71870 (12/17/2016), 72451 (1/7/2017), 73240 (3/8/2017), 72702 (3/30/2017), 77335 (8/10/2017), and 81025 (1/3/2018).
Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on returning or disposing of the affected products.
The recalled product
- Product
- ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 123
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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