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

Recall Z-1371-2015 — Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannu

U.S. FDA — Device Enforcement · United States · 2015-03-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1371-2015
Date of alert: 2015-03-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Edwards Lifesciences, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 59751073

Reported risk: Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.

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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