Z-1684-2015Class II

CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow...

Name: Z-1684-2015 CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow...
Creator: Codman & Shurtleff, Inc.
Published: 2015-03-05
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2015-03-05 / Terminated / root cause: manufacturing process

FDA source

Codman & Shurtleff, Inc. began a recall of CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN... on 2015-03-05. FDA classified it as Class II and gives the reason as "Needle is leaking from hub/needle cannula connection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1684-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-05
Posted: 2015-05-28
Terminated: 2017-02-16
Recalling firm: Cerenovus, Inc.
Product: CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. .
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Needle is leaking from hub/needle cannula connection
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Codman Neuro issued recall letter on 3/05/15 requested to immediately check all inventory to determine if you have affected product. Complete the Acknowledgement Form and follow the instructions to report your inventory status and return affected product for credit and replacement (if requested). General inquiries, customer service or field action logistics - please contact Codman Neuro Quality at: [email protected] or 866-491-0974.
Quantity in commerce: 5463 units
Distribution: Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Product codes and lots: Lot numbers: 14B114CT, 14E011CT, and 14E366CT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1684-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1684-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-28

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)