Z-1533-06

Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730

Name: Z-1533-06 Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
Creator: Codman & Shurtleff, Inc.
Published: 2006-08-04
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2006-08-04 / Terminated / root cause: packaging

FDA source

Codman & Shurtleff, Inc. began a recall of Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730 on 2006-08-04. The reason FDA records is "Sterility of device is compromised due to package seal defects". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1533-06
Status: Terminated
Initiated: 2006-08-04
Posted: 2006-09-29
Terminated: 2015-04-16
Recalling firm: Cerenovus, Inc.
Product: Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Numer: 82-1730
Reason for recall: Sterility of device is compromised due to package seal defects
Root cause tag: packaging
FDA root cause: Other
Action: Codman initiated the recall on 8/04/06 by telephone with formal follow-up fax.
Quantity in commerce: 15 units
Distribution: Class II Recall - Nationwide distribution ---- including states of FL, NC, TN, and TX.
Product codes and lots: Lot Number: CGHBKY

K954021Class IIExternal Drainage System (Eds and Eds II)Johnson & Johnson Professionals, Inc. / cleared 1995-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)