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Recall Observatory FDA recall evidence

Device product

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.

Z-0478-2016

November 17, 2015

Class I

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 72715
Status
Terminated
Classification
Class I
Quantity
34 devices
Official record key
device-enforcement:Z-0478-2016

Official wording

Reason: 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.

Code information: Item Number G03974 Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.