Home › XIAMEN COMPOWER MEDICAL TECH. CO., LTD › WNL Product
WNL Product
XIAMEN COMPOWER MEDICAL TECH. CO., LTD · Model CP641000+1A+NG · UDI-DI 06946430410481
CBP
Prescription
10
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities
Description
CPR Mask with Oxygen Port with alcohol pad and Nitril glove 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. The CPR Mask with Oxygen Port is intended for prescription use.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.