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

Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707 — recall Z-0809-2021

U.S. FDA — Device Enforcement · United States · 2020-12-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0809-2021
Date of alert
2020-12-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Medical Llc
Product category
device
Product type
Devices
Reported risk: A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.