Recall Z-1684-2015
Codman & Shurtleff, Inc. · initiated March 5, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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. .
Codes / lots: Lot numbers: 14B114CT, 14E011CT, and 14E366CT
Reason for recall
Needle is leaking from hub/needle cannula connection
FDA-determined 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.
Details
- Recall number
- Z-1684-2015
- Initiated
- March 5, 2015
- Posted by FDA
- May 28, 2015
- Terminated
- February 16, 2017
- Product code
- LKK – Pump, Infusion, Implanted, Programmable
- Quantity
- 5463 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA