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U.S. Department of Health and Human Services

Class 2 Device Recall ISOMED refill kit

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 Class 2 Device Recall ISOMED refill kitsee related information
Date Initiated by FirmFebruary 04, 2008
Date PostedSeptember 17, 2008
Recall Status1 Terminated 3 on October 13, 2010
Recall NumberZ-1903-2008
Recall Event ID 47755
PMA NumberP990034 
Product Classification Programmable, Implanted, Infusion Pump - Product Code LKK
ProductIsoMed 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.
Code Information Lot 60538731, Use by Date is May 10, 2009.
FEI Number 2182207
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionConsignees 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 in Commerce1982 kits
DistributionWorldwide -- 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LKK
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