FDA-Device2016-01-13Class I
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.
Stryker Sustainability Solutions
Hazard
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.
Sold states
US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
Affected count
34 devices
Manufactured in
10232 S 51st St, N/A, Phoenix, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0478-2016Don't want to check this manually?
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