PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: January 13, 2016 Initiated: November 17, 2015 #Z-0478-2016

Product Description

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.

Reason for Recall

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.

Details

Units Affected
34 devices
Distribution
US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
Location
Phoenix, AZ

Frequently Asked Questions

What product 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.. Recalled by Stryker Sustainability Solutions. Units affected: 34 devices.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 13, 2016. Severity: Critical. Recall number: Z-0478-2016.