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. .
This recall has been terminated (originally issued May 28, 2015).
- Company
- Codman & Shurtleff, Inc.
- Recall Initiated
- March 5, 2015
- Posted
- May 28, 2015
- Terminated
- February 16, 2017
- Recall Number
- Z-1684-2015
- Quantity
- 5463 units
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Needle is leaking from hub/needle cannula connection
Distribution
Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Lot / Code Info
Lot numbers: 14B114CT, 14E011CT, and 14E366CT
Root Cause
Process control
Action Taken
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: CodmanProductComplaints@DPYUS.JNJ.com or 866-491-0974.