Z-2030-2011

Codman Metal Disposable ICP Kit

Name: Z-2030-2011 Codman Metal Disposable ICP Kit
Creator: Codman & Shurtleff, Inc.
Published: 2010-11-30
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2010-11-30 / Terminated / root cause: packaging

FDA source

Codman & Shurtleff, Inc. began a recall of Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic... on 2010-11-30. The reason FDA records is "Packaging defect may compromise sterility of device". 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-2030-2011
Status: Terminated
Initiated: 2010-11-30
Posted: 2011-04-20
Terminated: 2013-03-14
Recalling firm: Cerenovus, Inc.
Product: Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures
Product code: GWM Device, Monitoring, Intracranial Pressure
Reason for recall: Packaging defect may compromise sterility of device
Root cause tag: packaging
FDA root cause: Package design/selection
Action: The firm, Codman, sent an "Important Notice Urgent- Voluntary Product Recall Notification" letter dated November 30, 2010 to its customers via FedX. On January 7, 2011, Codman expanded the recall to four additional product codes.On January 31, 2011, the firm issued a supplemental recall letter and identified one additional product code: 80-11197. The letters described the product, problem and actions to be taken. The customers were instructed to identify the unused affected products in their inventory and follow the recall instructions provided: 1) If you have NO product to return, please advise Codman as soon as possible using the FACSIMILE form attached and fax to 508-828-6118 and 2) if you DO have product to return, please call 1-800-225-0460, Option 4, for instructions for return. Codman is presently working toward supplying replacement products as soon as possible. Please call Customer Service to check on the status of product availability at 1-800-225-0460. Should you have any questions regarding this recall, please call Customer Service at 1-800-225-0460 or your local Codman Representative.
Quantity in commerce: 1671 units
Distribution: Worldwide distribution: USA including states of :AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI and WV; and countries including: Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom.
Product codes and lots: Lot Codes: 421298 422002 SW103730 444161 KA291 AB243 DB319 FB302 JB212

Product code GWM

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)