The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1276-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls Breast Augmentation Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 1,436 breast augmentation kits because the disposable gloves included 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 risk-of-harm product (sterile medical device) where the hazard is compromised sterility, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 1,436 Breast Augmentation Packs, including part numbers AMS1786(A, AMS2790(A, AMS3324(B, AMS4382, AMS4382(A, AMS4382(B, AMS4392, and PSS3430. The recall involves Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits.

The recall was initiated because the gloves may contain splits or holes, which could compromise the sterility of the medical devices. The affected kits 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.

Healthcare providers and consumers who have these specific kits should stop using them and contact Windstone Medical Packaging, Inc. for instructions on return or replacement. The recall covers specific lot numbers and expiration dates ranging from January 2017 to September 2019.

The recalled product

Product
Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part…
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
1,436

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 (20)

  • Lot number and expiration date 100634
  • 9/23/2018 83241
  • 6/20/2017 83757
  • 6/1/2017 84174
  • 1/14/2017 84249
  • 1/20/2017 84496
  • 6/21/2017 84521
  • 3/19/2017 84904
  • 4/28/2017 84910
  • 1/25/2017 85071
  • 11/30/2017 85126
  • 6/28/2017 85126
  • 6/28/2017 85162
  • 1/17/2017 85565
  • 1/24/2017 85634
  • 6/11/2017 85820
  • 3/25/2017 85831
  • 6/14/2017 85985
  • 7/15/2017 86062
  • 4/21/2017 86141

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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