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GALEMED CORPORATION · Model 2690 · UDI-DI 04710810100796
BYE
Prescription
1
510(k) clearances
254
Adverse events (34 deaths)
10
Recalls
72
Facilities
Description
Babi.Plus Bubble PAP Valve 0 - 10 cm H2O
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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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.