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.
FDA Recall Z-1568-2014 · Posted 2014-05-08
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Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLKK
Date Initiated2014-04-04
Date Terminated2014-11-05
Product Quantity13,784
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.
Firm Action
Medtronic sent a "Medical Device Removal" letter dated April 2014 hand delivered, e-mail or faxed to affected customers. The letter described the problem and the product affected by the recall. The letter also contained the Action Required, Additional Information (Contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm Central Time) and requested consignees to complete and fax or e-mail the "Medical Device Removal Reply Form".
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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