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CODMAN® BACTISEAL®
INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 821749 · UDI-DI 10381780537014
1
510(k) clearances
157
Adverse events (4 deaths)
6
Recalls
19
Facilities
Description
CODMAN® EVD BACTISEAL® 1.9mm I.D. Catheter Set MR SAFE Contents: 35cm Ventricular Catheter (1), Connector (1), Cap (1), Catheter Anchoring Clip (1); Additional Contents: Trocar (1), Stylet (1)
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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