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mcompass Extension Tube Set
MEDSPIRA, LLC · Model RMD-002-006 · UDI-DI 00851607003181
1
510(k) clearances
7
Adverse events
1
Recalls
15
Facilities
Description
Medspira mcompass Extension Tube Set
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-04-06 | Medtronic Gastroenterology / Urology | Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is |
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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.