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

Recall Z-0061-2021 — Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original eq

U.S. FDA — Device Enforcement · United States · 2020-09-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0061-2021
Date of alert
2020-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medline Industries Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
65021652
Reported risk: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
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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