Data Foundry

Medical device recalls 2015

CODMAN 3000 Series Refill Set- Huber needles — Class II medical device recall Z-1684-2015

Terminated recall by Codman & Shurtleff, Inc., reported 2015-06-03, distributed nationwide. Needle is leaking from hub/needle cannula connection

Recall numberZ-1684-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCodman & Shurtleff, Inc., Raynham, MA, United States
Recall initiated2015-03-05
Classified2015-05-28
Reported by FDA2015-06-03
Terminated2017-02-16
DistributedNationwide (US)
Countries outside the USCA, CH, DE, FR
Quantity5,463 units
Reason classespackaging
Lot numbers14B114CT, 14E011CT, 14E366CT
Model numbersAP-07014

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. .

Reason for recall

Needle is leaking from hub/needle cannula connection

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1684-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.