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RONDEX CPR ISO-VALVE (Made in USA)
RONDEX PRODUCTS, INCORPORATED · Model 4040 (packaged in polybag) · UDI-DI 06343760040409
1
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities
Description
The RONDEX CPR ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask. It contains a total of two (2) silicone valves to help isolate the rescuer from the patient's breath. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA (ISO-VALVE(TM) of Rondex Products, Inc.)
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.