Codman & Shurtleff, Inc. recalls CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable…

Recall date

March 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1684-2015

FDA classification

Class II

Brand / firm

Codman & Shurtleff, Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.

Why it was recalled

Needle is leaking from hub/needle cannula connection

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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. .