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Cook

COOK INCORPORATED · Model G19891 · UDI-DI 00827002198913

PFJ Prescription
2
510(k) clearances
132
Adverse events (8 deaths)
1
Recalls
2
Facilities

Description

Cook, Cervical Ripening Balloon With Stylet

Recalls

DateFirmReason
2015-12-03Ethicon, Inc.Stability data does not substantiate the labeled two-year shelf life of affected product.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.