Windstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 15 Abdominoplasty Packs 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 gloves) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 15 Abdominoplasty Packs, Kit number AMS3326. These convenience custom kits are used for general surgery in hospital operating rooms. The recall is limited to specific lots with expiration dates of August 3, 2016, and August 12, 2016.
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 stop using these kits and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number/ Expiration Date: 71658 8/3/2016 73140 8/12/2016
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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