Home › Intersurgical Incorporated › 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE
22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE
Intersurgical Incorporated · Model 5191000 · UDI-DI 05030267069866
CBP
Prescription
10
510(k) clearances
55
Adverse events (10 deaths)
7
Recalls
69
Facilities
Description
22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE AND 6MM MONITORING LINE 1.8
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.