Z-0478-2016 Class I Terminated
FDA device recall Z-0478-2016 was initiated by Stryker Sustainability Solutions on Nov 17, 2015 and is designated Class I. 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 recall status is terminated (terminated Sep 28, 2016). Affected quantity: 34 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 13, 2016
- Initiation Date
- Nov 17, 2015
- Termination Date
- Sep 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 devices
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.
Distribution Pattern
US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
Code Information
Item Number G03974 Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0478-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026