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RESPI-CHECK ADULT BREATHING INDICATOR HIGH CONCENTRATION OXYGEN MASK WITH TUBE

Intersurgical Incorporated · Model 1202000 · UDI-DI 05030267051991

KGB Prescription
10
510(k) clearances
175
Adverse events (6 deaths)
8
Recalls
151
Facilities

Description

RESPI-CHECK™, ADULT, BREATHING INDICATOR HIGH CONCENTRATION OXYGEN MASK WITH TUBE, 2.1M

Recalls

DateFirmReason
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11Westmed, Inc.There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2004-07-12Medex IncThe non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
2004-07-12Medex IncThe non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.