Agency classClass IIOur severity:Severe FDA (Devices)·Z-2917-2016·Announced 2016-10-12

Cardinal Health Recalls Blue Impervious Gowns for Flammability Defect

Cardinal Health is recalling Blue Impervious Gowns, X-Large, because they failed to meet federal flammability standards for vinyl plastic film.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a failure to meet federal flammability standards (16 CFR 1611), which presents a significant fire hazard. Per the rubric, significant injury or property damage risks associated with structural or safety defects warrant a Severe rating.

Plain-English summary

Cardinal Health is recalling approximately 4,062,511 units of Blue Impervious Gown with Thumbhooks, X-Large. These non-sterile, single-use plastic isolation gowns are intended to serve as a physical barrier to the transfer of microorganisms, body fluids, and particulate material.

The recall was initiated because the gowns do not meet design specifications, specifically 16 CFR 1611, the Standard for the Flammability of Vinyl Plastic Film. Testing revealed that the gowns failed in the machine direction with a flame propagation rate of 1.9-2.0 inches per second, exceeding the limit of 1.2 inches per second. The gowns passed testing in the cross direction by self-extinguishing.

The affected products were distributed nationwide to consignees in Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, and West Virginia. All lots with material numbers 5213PG and V5213PG are affected. Consumers and healthcare facilities should stop using these gowns and contact Cardinal Health for further instructions.

The recalled product

Product: BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material.…
Manufacturer: Cardinal Health
Category: Medical Device — Isolation Gowns
Hazard: fire
flammability
Affected units: 4,062,511

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 (1)

All Lots with material number 5213PG and V5213PG

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Same manufacturer · Cardinal Health

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