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INTRODUCER SHAFT
SONTEC INSTRUMENTS, INC. · Model 2800-514 · UDI-DI 00192896070097
5
510(k) clearances
86
Adverse events
3
Recalls
152
Facilities
Description
HEARTLINE INTRODUCER SHAFT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2015-11-25 | Abeon Medical Corporation | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
| 2015-11-25 | Abeon Medical Corporation | The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. |
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