Z-1684-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2015
- Initiation Date
- March 5, 2015
- Termination Date
- February 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5463 units
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. .
Reason for Recall
Needle is leaking from hub/needle cannula connection
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Code Information
Lot numbers: 14B114CT, 14E011CT, and 14E366CT