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

Recall Z-1965-2013 — Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

U.S. FDA — Device Enforcement · United States · 2013-07-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1965-2013
Date of alert: 2013-07-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Arrow International Inc
Product category: device
Product type: Devices

Reported risk: Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.

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.

Recall Z-1965-2013 — Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.

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