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AESCULAP
AESCULAP, INC. · Model MB170R · UDI-DI 04046964589539
HDQ
Prescription
6
510(k) clearances
12
Adverse events
4
Recalls
153
Facilities
Description
WALTHER DILATOR-CATHETER 14 FR 135MM
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.