Z-1568-2014 Class II Terminated
FDA device recall Z-1568-2014 was initiated by Medtronic Neuromodulation on Apr 4, 2014 and is designated Class II. Reason for recall: Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem… The recall status is terminated (terminated Nov 5, 2014). Affected quantity: 13,784.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- Apr 4, 2014
- Termination Date
- Nov 5, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,784
Product Description
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
Reason for Recall
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
Code Information
Lot numbers CS3643, CS3613, CS3663, N441998, N442081, N442131, N440259, N440527, N440582, N440654, N440909, N440978, N441199, N441268, N441806, N441817, N442178, N442513, N442532, N442560, N442588, N442831, and N443427. Affected lots were distributed between January 2014 and March 2014.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1568-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026