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

Recall Z-2478-2015 — FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conve

U.S. FDA — Device Enforcement · United States · 2015-08-12 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2478-2015
Date of alert: 2015-08-12
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Abbott Electrophysiology
Product category: device
Product type: Devices

Reported risk: The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. The manufacturing date was accidentally used (copied) for the expiration date.

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.

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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