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Harrison

COOK INCORPORATED · Model G16766 · UDI-DI 00827002167667

MPR Prescription
0
510(k) clearances
27
Adverse events (3 deaths)
1
Recalls
3
Facilities

Description

Harrison Fetal Bladder Stent Set

Recalls

DateFirmReason
2019-08-01Rocket Medical PlcA complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used

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Data 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.