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CPR Bio-Barrier Training Faceshield
O-Two Medical Technologies Inc · Model 01RB5050U · UDI-DI 07540195056008
CBP
Prescription
1
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities
Description
CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. The use if this device does not guarantee complete protection from disease transmission.
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.