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PEEP VALVE 7.5cmH2O

BESMED HEALTH BUSINESS CORP. · Model CT-20300 · UDI-DI 04716770203003

BYE Prescription

510(k) clearances

254

Adverse events (34 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2019-01-15	Westmed, Inc.	A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with i
2019-01-15	Westmed, Inc.	A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with i
2019-01-15	Westmed, Inc.	A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with i
2015-09-24	Airways Development LLC	Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an is
2008-03-04	Smiths Medical ASD, Inc.	Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of ai
2008-03-04	Smiths Medical ASD, Inc.	Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of ai
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
2007-08-21	Ambu Incorporated	Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.

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Data 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.