Windstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk
Windstone Medical Packaging is recalling 546 custom breast augmentation kits because the included Medtronic gloves 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 (glove splits/holes) compromises sterility, creating a risk of harm (infection) in a surgical setting. No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 546 units of Custom Breast Augmentation Packs (Kit numbers PSS2455(B, PSS2455(C, and PSS2455(D). These convenience custom kits are 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 AMS kit.
The gloves may contain splits or holes, which compromises the sterility of the kit. This defect poses a risk of infection to patients during surgery. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Healthcare facilities should stop using the affected kits immediately. Consumers or patients who have had surgery using these kits should contact their healthcare provider if they have concerns about potential infection. The specific lot numbers and expiration dates for the affected kits range from August 2013 to July 2016.
The recalled product
- Product
- Custom Breast Augmentation Pack, Kit number PSS2455(B, PSS2455(C, PSS2455(D convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 546
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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