Home › RONDEX PRODUCTS, INCORPORATED › Rondex CPR Pocket Rescue Mask (Made in USA) #9140
Rondex CPR Pocket Rescue Mask (Made in USA) #9140
RONDEX PRODUCTS, INCORPORATED · Model 9140 (packaged in clamshell case) · UDI-DI 06343760091401
1
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities
Description
The Rondex CPR Pocket Rescue Mask, Model #9140, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA
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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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.