Windstone Medical Recalls Pacemaker Kits Due to Sterility Compromise
Windstone Medical Packaging is recalling 561 pacemaker 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 medical device where a defect compromises sterility, creating a risk of harm (infection) even though no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 561 Pacemaker Kits, part number AMS4281, AMS4281(A, AMS4281(C, and AMS4281(D. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. The gloves may contain splits or holes, which compromises the sterility of the product.
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 ranging from May 3, 2018, to June 12, 2019.
Healthcare facilities and consumers should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Pacemaker Kit, part number AMS4281 Pacemaker Kit, part number AMS4281(A Pacemaker Kit, part number AMS4281(C Pacemaker Kit, part number AMS4281(D
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 561
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 (14)
- Lot number and expiration date 80492
- 5/3/2018 82502
- 6/8/2018 85302
- 7/12/2018 88153
- 11/13/2018 89116
- 12/10/2018 89318
- 11/22/2018 95070
- 1/29/2019 95088
- 11/14/2018 95580
- 1/4/2019 95581
- 1/4/2019 95582
- 1/11/2019 95583
- 1/24/2019 97115
- 6/12/2019
Distribution
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
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