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Terminated

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. .

FDA Recall Z-1684-2015 · Posted 2015-05-28

Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeLKK
Date Initiated2015-03-05
Date Terminated2017-02-16
Product Quantity5463 units

Reason for Recall

Needle is leaking from hub/needle cannula connection

Firm 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: [email protected] or 866-491-0974.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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