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AESCULAP
Aesculap AG · Model ET270R · UDI-DI 04038653155064
KOH
Prescription
10
510(k) clearances
97
Adverse events
2
Recalls
83
Facilities
Description
SELLHEIM Obstetrical Spoon, 11 3/4", (300 mm), non-sterile, reusable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-15 | Boston Scientific Corporation | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection |
| 2003-02-20 | Portex, Inc | May have incorrectly printed graduation markings along the tube shaft. |
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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.