Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0478-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2015-11-17 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0478-2016
Date of alert
2015-11-17
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Stryker Sustainability Solutions
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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