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AMBLER SURGICAL CORP. · Model Cottle septum speculum · UDI-DI 00190660216481
EPY
Prescription
10
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities
Description
Cottle septum speculum, 5 1/2'', narrow, 90.0mm long, tapered 10mm to 8mm wide blades, with set screw
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. |
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