Reported Jun 3, 2015 · Terminated
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable…
Codman & Shurtleff, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Codman & Shurtleff, Inc. · 325 Paramount Drive · Raynham, MA · 02767
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
AP-07014 | Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump 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. . |
- Lot codes and dates
- Lot numbers
14B114CT14E011CTand 14E366CT
- Lot numbers
- Amount recalled
- 5463 units
Where it was sold
- Nationwide
Why it was recalled
Needle is leaking from hub/needle cannula connection
This product could cause temporary or reversible health problems — stop using it.
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