FDA-Device2015-06-03Class II
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. .
Codman & Shurtleff, Inc.
Hazard
Needle is leaking from hub/needle cannula connection
Sold states
Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Affected count
5463 units
Manufactured in
325 Paramount Drive, Raynham, MA, United States
Products
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. .
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2015Don't want to check this manually?
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