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Terminated

Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog Number: 82-1731

FDA Recall Z-1534-06 · 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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