Recall Z-0478-2016— Stryker Sustainability Solutions
Class I · Terminated
Class I FDA medical device recall by Stryker Sustainability Solutions, initiated 2015-11-17, terminated 2016-09-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-11-17
- Terminated
- 2016-09-28
- Firm location
- Phoenix, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.