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

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. — recall Z-2838-2020

U.S. FDA — Device Enforcement · United States · 2020-07-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2838-2020
Date of alert: 2020-07-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Datascope Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 3000049797

Reported risk: Potential Endotoxin Contamination

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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