CODMAN 3000 Series Refill Set- Huber needles recallZ-1684-2015 · Codman & Shurtleff, Inc. · initiated Mar 5, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Needle is leaking from hub/needle cannula connection
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1684-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 5, 2015
- Posted by the FDA
- May 28, 2015
- Recalling firm
- Codman & Shurtleff, Inc.
- Quantity
- 5463 units
- Product code
- LKK
- FDA submissions
- P890055
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Product description
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. .
Code information (models, lots, serial numbers)
Lot numbers: 14B114CT, 14E011CT, and 14E366CT
Other devices under the same FDA submission
6 devices cleared under P890055 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CODMAN AP-03000HCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths32 reports
- CODMAN AP-03000LCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE17 reports
- NA IP-37957Medos International Sàrl · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE6 reports
- CODMAN AP-03000MCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE3 reports
- MEDSTREAM 91-4201USCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE3 reports
- CODMAN AP-03000ULCerenovus, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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