Home › Laerdal Medical AS › BoundTree CPR Mask w/O2, one-way valve and filter
BoundTree CPR Mask w/O2, one-way valve and filter
Laerdal Medical AS · Model 830047 · UDI-DI 07045430044647
10
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities
Description
The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source.
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.