The Recall Desk
HighFDA (Devices)·Z-1287-2017·Announced 2017-03-08

Windstone Medical Packaging Recalls D & C Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 136 D & C Kits because the disposable gloves included may contain splits or holes that compromise sterility.

What this means for you

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 (splits/holes) compromises sterility, creating a risk of infection or harm. This fits the rubric for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 136 D & C Kits, part number CMP1466(A. The recall is due to a potential 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 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. The recall covers specific lot numbers and expiration dates, including 85461 (8/5/2018), 86216 (8/24/2018), 87933 (11/15/2018), 96803 (3/8/2019), 97312 (5/5/2019), and 98203 (6/6/2019).

Healthcare facilities and consumers 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 supplier or the recalling firm, Windstone Medical Packaging, Inc.

The recalled product

Product
D & C Kit, part number CMP1466(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
136

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 (7)

  • Lot number and expiration date 85461
  • 8/5/2018 86216
  • 8/24/2018 87933
  • 11/15/2018 96803
  • 3/8/2019 97312
  • 5/5/2019 98203
  • 6/6/2019

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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