Recall Z-1684-2015 ยท LKK Pump, Infusion, Implanted, Programmable
Codman & Shurtleff, Inc.
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. .
| Date | May 28, 2015 (initiated Mar 5, 2015) |
| Status | Terminated |
| Reason | Needle is leaking from hub/needle cannula connection |
| Root cause | 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 | 5463 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.