Recall Z-1684-2015— Codman & Shurtleff, Inc.
Class II · Terminated
Class II FDA medical device recall by Codman & Shurtleff, Inc., initiated 2015-03-05, terminated 2017-02-16. FDA's recall record names no specific 510(k) clearance for this event. 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: Needle is leaking from hub/needle cannula connection.
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-05
- Terminated
- 2017-02-16
- Firm location
- Raynham, MA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.