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PANPAC MEDICAL CORPORATION · Model OS265BA-1-W · UDI-DI 04715309129456
HDQ
Prescription
6
510(k) clearances
12
Adverse events
4
Recalls
153
Facilities
Description
These Cervical Dilators are especially useful in locating and dilating the external OS, the cervical canal and the internal OS. They are particularly valuable instruments to be used on post-menopausal patients with cervical stenosis.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2009-04-09 | Marina Medical Instruments Inc. | Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was |
| 2009-04-09 | Marina Medical Instruments Inc. | Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not p |
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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.