The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1283-2017·Announced 2017-03-08

FDA Recalls Custom Breast Augmentation Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 229 Custom Breast Augmentation Packs because the included 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 is classified as FDA Class II and involves a risk of harm (compromised sterility) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 229 units of the Custom Breast Augmentation Pack, part number PSS2455(D, manufactured by Windstone Medical Packaging, Inc. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. These gloves may contain splits or holes that compromise sterility.

The affected products were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington. Specific lot numbers and expiration dates for the affected kits include 100294 (5/29/2018), 84142 (5/25/2017), 85025 (5/25/2017), 88222 (5/25/2017), 88310 (5/25/2017), 89226 (5/25/2017), 96139 (7/6/2017), 96969 (7/30/2017), and 97625 (7/27/2017).

Healthcare providers and facilities should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The FDA has not reported any illnesses or injuries associated with this recall.

The recalled product

Product
Custom Breast Augmentation Pack, part number PSS2455(D
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
229

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 (10)

  • Lot number and expiration date 100294
  • 5/29/2018 84142
  • 5/25/2017 85025
  • 5/25/2017 88222
  • 5/25/2017 88310
  • 5/25/2017 89226
  • 5/25/2017 96139
  • 7/6/2017 96969
  • 7/30/2017 97625
  • 7/27/2017

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 124 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 124 products in this recall →

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