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

Recall Z-1324-2018 — (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+ard Blue(R) MAC(TM) T

U.S. FDA — Device Enforcement · United States · 2017-12-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1324-2018
Date of alert
2017-12-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Reported risk: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
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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