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ColpotomizOR Tube
THE O R COMPANY PTY LTD · Model C35-TV · UDI-DI 09349967002575
HEW
Prescription
10
510(k) clearances
251
Adverse events
4
Recalls
22
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-23 | CooperSurgical, Inc. | The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required. |
| 2019-06-14 | CooperSurgical, Inc. | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health cons |
| 2019-06-14 | CooperSurgical, Inc. | The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health cons |
| 2018-09-04 | CooperSurgical, Inc. | The seal of the sterile pouch may be compromised, thereby increasing the risk of infection. |
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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.