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BLACK & BLACK SURGICAL, INC. · Model B89120 · UDI-DI 00840329800307
BYY
Prescription
10
510(k) clearances
216
Adverse events (2 deaths)
6
Recalls
170
Facilities
Description
COUPLING PIECE FOR CANISTER LID 89119
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-15 | DeRoyal Industries Inc | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay i |
| 2008-04-21 | Mentor Texas, Inc | During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
| 2003-11-07 | Vital Concepts, Inc. | The probe may separate from the cannula. |
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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.