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BIB®
B BRAUN INTERVENTIONAL SYSTEMS, INC · Model 614392 · UDI-DI 04046964899720
NVM
Prescription
2
510(k) clearances
26
Adverse events
2
Recalls
3
Facilities
Description
BB044 BIB Catheter 8 4.5 8F
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-21 | Numed Inc | Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled |
| 2006-06-20 | Arrow International Inc | The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed. |
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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.