Agency classClass IIOur severity:High FDA (Devices)·Z-0161-2017·Announced 2016-10-26

Windstone Medical Recalls Cardiac Cath Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 138 Cardiac Cath Packs because the disposable gloves included in the kits 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 is classified as FDA Class II. The hazard involves compromised sterility in a surgical setting, which poses a risk of infection (harm) but the source does not report specific injuries or illnesses, 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 138 units of Cardiac Cath Pack, kit number AMS2707. 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 product. The affected lots have expiration dates ranging from November 2015 to December 2016. The specific lot numbers and expiration dates are: 67078 (11/16/2015), 66903 (11/26/2015), 64343 (12/24/2015), 68965 (9/10/2016), 68647 (9/18/2016), 68147 (9/28/2016), 70233 (10/30/2016), and 71064 (12/7/2016).

The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Hospitals and healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.

The recalled product

Product: Cardiac Cath Pack, kit number AMS2707 convenience custom kits used for general surgery in hospital operating room
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
infection-risk
Affected units: 138

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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.

See all 150 products in this recall →

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Same hazard · sterility compromise