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Ambler Surgical
AMBLER SURGICAL CORP. · Model Gruber ear speculum · UDI-DI 00190660178765
EPY
Prescription
10
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities
Description
Gruber ear speculum, heavy, oval ends, set of 3 includes sizes #1 - #3 (86-401, 86-402 and 86-403)
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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