Recall Z-1903-2008 ยท LKK Pump, Infusion, Implanted, Programmable
Medtronic Neuromodulation
IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated drape, Template; Use by Date May 10, 2009; Medtronic, Inc., Minneapolis, MN. Product is packaged in a sterile container.
| Date | Sep 17, 2008 (initiated Feb 4, 2008) |
| Status | Terminated |
| Reason | Medtronic is retrieving all unused packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was released using incorrect endotoxin specification limits. Endotoxin contamination can potentially lead to fever, malaise, respiratory distress, septic shock, and death. |
| Root cause | Process control |
| Action | Consignees were notified by Medtronic field personnel, either by personal visits or telephone, beginning 2/4/08. This included the 8 additional consignees located outside of the U.S. Medtronic advised customers not to use any unused packages in their inventory and that a field representative would assist them in returning the product for replacement and/or credit. Upon completion of each follow-up, the field representatives completed and returned a Reply Card documenting the notification. If you have questions or comments, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 |
| Quantity | 1982 kits |
| Distribution | Worldwide -- including the U.S. (AK, AL, AR, AZ, CA, CT, DC,DE, FL, GA, HI, ID, IL, IN, KY, LA, MA, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, and WV) and Argentina, Australia, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.