Recalls / —
—#70072
Product
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.
- FDA product code
- LKK — Pump, Infusion, Implanted, Programmable
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P990034
- Affected lot / code info
- Lot 60538731, Use by Date is May 10, 2009.
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2008-02-04
- Posted by FDA
- 2008-09-17
- Terminated
- 2010-10-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #70072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.