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QLRAD
QLRAD INTERNATIONAL LTD · Model 105.1018 · UDI-DI 08719326258263
1
510(k) clearances
1
Adverse events
2
Recalls
7
Facilities
Description
RectalPro75, switch valve LL with 100 cc Syringe
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-04 | Angiodynamics, Inc. | Product is mislabeled with the incorrect fill volume. |
| 2024-05-21 | Angiodynamics, Inc. | A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch iden |
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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.