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RespondER Emergency Rescue CPR Mask with Oxygen Port

Allied Medical Products · Model AMP0825 · UDI-DI 00852696007012

CBP Prescription
10
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities

Description

RespondER Emergency Rescue CPR Mask with Oxygen Port is a non-invasive face shield with an integral/removable non-rebreathing valve which serves as a physical barrier for rescuers providing immediate life support to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.

Recalls

DateFirmReason
2016-05-16Lifeline First Aid LLCFirst aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and
2016-05-16Lifeline First Aid LLCCadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cle
2014-07-02Dynarex Corporation"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.
2004-02-03Rusch IncValve cap may become loose and enter the air circuitry.

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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.