Device 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. .
Z-1684-2015
Product summary
- Event
- Event 70659
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5463 units
- Official record key
device-enforcement:Z-1684-2015
Official wording
Reason: Needle is leaking from hub/needle cannula connection
Code information: Lot numbers: 14B114CT, 14E011CT, and 14E366CT
Distribution pattern: Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Derived failure modes
-
Unknown
Needle is leaking from hub/needle cannula connection