Z-2298-2013Class I

MedStream Refill Kit, U.S (6 units): 91-4288

Name: Z-2298-2013 MedStream Refill Kit, U.S (6 units): 91-4288
Creator: Codman & Shurtleff, Inc.
Published: 2013-08-13
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2013-08-13 / Terminated

FDA source

Codman & Shurtleff, Inc. began a recall of MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US... on 2013-08-13. FDA classified it as Class I and gives the reason as "Drug flow rates exceeding programmed flow rates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2298-2013
Classification: Class I
Status: Terminated
Initiated: 2013-08-13
Posted: 2013-09-30
Terminated: 2014-09-11
Recalling firm: Cerenovus, Inc.
Product: MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Drug flow rates exceeding programmed flow rates.
FDA root cause: Use error
Action: Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice letter dated August 13, 2013 to US Consignees via FedEx overnight delivery and International Consignees were notified of the recall via email. The letter identifed the affected products, potential clinical impact, and updated IFU pump filling warning. The letter informed consignees that the Instructions for Use (IFU) and product training materials had been updated by adding a warning statement about potential over infusion if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling technique. Consignees are asked to complete the Field Safety Notice Acknowledgement Form and return it to your local Codman Neuro Sales Representative or fax to: 508-977-6665. Consignees are asked to contact your Codman Neuro representative if they have questions, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to 1-866-491-0974, Option 2.
Quantity in commerce: 0 - product used for internal training purposes only
Distribution: Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2298-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2293-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2294-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2295-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2296-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2297-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2298-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2299-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30
Z-2300-2013	Class I	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

Product code LKK

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