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

Recall Z-1389-2017 — Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.

U.S. FDA — Device Enforcement · United States · 2017-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1389-2017
Date of alert
2017-02-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
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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