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.

Recall Insight

This FDA Devices action (record #Z-0478-2016) was formally reported on January 13, 2016, with the manufacturer initiating the action on November 17, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Stryker Sustainability Solutions is listed as the recalling firm, operating out of Phoenix, AZ. Federal records indicate 34 devices units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.