Z-1684-2015 Class II Terminated

Recalled by Codman & Shurtleff, Inc. — Raynham, MA

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