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

Recall Z-2705-2017 — O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients

U.S. FDA — Device Enforcement · Canada · 2015-06-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2705-2017
Date of alert
2015-06-23
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
O-Two Medical Technologies, Inc.
Product category
device
Product type
Devices
Reported risk: Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
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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