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U.S. Department of Health and Human Services

Class 2 Device Recall Codman 3000 Series Refill Set

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  Class 2 Device Recall Codman 3000 Series Refill Set see related information
Date Initiated by Firm March 05, 2015
Date Posted May 28, 2015
Recall Status1 Terminated 3 on February 16, 2017
Recall Number Z-1684-2015
Recall Event ID 70659
PMA Number P890055 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
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.

Code Information Lot numbers: 14B114CT, 14E011CT, and 14E366CT
Recalling Firm/
Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact
Manufacturer Reason
for Recall
Needle is leaking from hub/needle cannula connection
FDA Determined
Cause 2
Process control
Action Codman Neuro issued recall letter on 3/05/15 requested to immediately check all inventory to determine if you have affected product. Complete the Acknowledgement Form and follow the instructions to report your inventory status and return affected product for credit and replacement (if requested). General inquiries, customer service or field action logistics - please contact Codman Neuro Quality at: CodmanProductComplaints@DPYUS.JNJ.com or 866-491-0974.
Quantity in Commerce 5463 units
Distribution Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = Intera Oncology