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LiNA OperaScope™ Tubing & Drape kit
LiNA Medical AG · Model OP-TDK-6 · UDI-DI 05708265018024
PXU
Prescription
0
510(k) clearances
15
Adverse events (2 deaths)
1
Recalls
20
Facilities
Description
Tubing & drape for hysteroscopy and cystoscopy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-11 | Merit Medical Systems, Inc. | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
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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.