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DuoRipe
Coopersurgical, Inc. · Model J-CRB-184000 · UDI-DI 00888937027877
PFJ
Prescription
1
510(k) clearances
132
Adverse events (8 deaths)
1
Recalls
2
Facilities
Description
DuoRipe Cervical Ripening Balloon
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-12-03 | Ethicon, Inc. | Stability data does not substantiate the labeled two-year shelf life of affected product. |
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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.