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AESCULAP
Christoph Miethke GmbH & Co. KG · Model FV077P · UDI-DI 04041906120405
HCA
Prescription
10
510(k) clearances
157
Adverse events (4 deaths)
6
Recalls
19
Facilities
Description
Ventricular Catheter marked, with mandrin, 9 3/4" (250 mm), inner diam. 1,20 mm, outer diam. 2,50 mm, silicone, sterile, disposable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-17 | Integra LifeSciences Corp. | Incorrect labeling, Catheter did not have the required holes and markings |
| 2005-03-24 | Vygon Neuro | stylet in package is shorter than that claimed on the label |
| 2005-03-24 | Vygon Neuro | stylet in package is shorter than that claimed on the label |
| 2005-03-24 | Vygon Neuro | stylet in package is shorter than that claimed on the label |
| 2004-03-11 | Codman & Shurtleff, Inc. | Drainage tips absent from catheter tip |
| 2003-03-19 | Integra Life Sciences Corp. | The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottl |
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