Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2917-2016 — 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. Level of barrier pro

U.S. FDA — Device Enforcement · United States · 2016-07-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2917-2016
Date of alert
2016-07-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health
Product category
device
Product type
Devices
Reported risk: Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be performed on different orientations of the film (machine direction and cross direction). The machine direction is defined by the manufacturing process generating the film. The formed film exits the machine moving in the machine direction. The cross direction is at 90 degrees to the machine direction. The more rapid burning direction defines the results of the test (either a pass or fail). The products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. They passed by self-extinguishing when tested in the cross direction.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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