Stryker Sustainability Solutions recalls The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigta…

Recall date

November 17, 2015

Source

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

Recall number

Z-0478-2016

FDA classification

Class I

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.

Why it was recalled

Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.