CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable
FDA device recall Z-1684-2015 · posted 2015-05-28 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Needle is leaking from hub/needle cannula connection
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 5463 units
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
- Date initiated
- 2015-03-05
- Date posted
- 2015-05-28
- Date terminated
- 2017-02-16
- Location
- Raynham, MA
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