Cook Inc. recalls Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothor…

Recall date

September 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0506-2020

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.

Why it was recalled

Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.