Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
FDA Recall Z-1533-06 · Posted 2006-09-29
Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Date Initiated2006-08-04
Date Terminated2015-04-16
Product Quantity15 units
Reason for Recall
Sterility of device is compromised due to package seal defects
Firm Action
Codman initiated the recall on 8/04/06 by telephone with formal follow-up fax.
Root Cause
Other
Distribution Pattern
Class II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.