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WNL Product

XIAMEN COMPOWER MEDICAL TECH. CO., LTD · Model CP641000+CP641007+1A+NG · UDI-DI 06946430413253

CBP Prescription

510(k) clearances

Adverse events (10 deaths)

Recalls

Facilities

Description

Cardiopulmonary resuscitation kit contains CPR Mask with Oxygen Port, Infant CPR Mask without Oxygen Port, one pieces alcohol pads and one pair Nitrile glove. CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. Infant CPR Mask without Oxygen Port is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user. It is intended for Rx only and for infants with body weight up to 10kg (22 lbs).

Recalls

Date	Firm	Reason
2016-05-16	Lifeline First Aid LLC	First 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
2016-05-16	Lifeline First Aid LLC	Cadillac 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
2014-07-02	Dynarex 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.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.
2004-02-03	Rusch Inc	Valve 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.