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U.S. Department of Health and Human Services

Class 2 Device Recall Lioresal Intrathecal Refill Kit, model 8561

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  Class 2 Device Recall Lioresal Intrathecal Refill Kit, model 8561 see related information
Date Initiated by Firm November 19, 2004
Date Posted January 13, 2005
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-0391-05
Recall Event ID 30503
PMA Number P860004 
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
Product Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray.

Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer''s label and lot number 007J2583. The drug box is labeled with Lot 017H1925.

Medtronic packages a manufacturer''s labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly (''Lioresal Refill Kit'') will display the Medtronic lot number (N0016487).

The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK.
Code Information N0016487
Recalling Firm/
Manufacturer		 Medtronic Inc, Neurological & Spinal Division
800 53rd Ave Ne
Columbia Heights MN 55421-1241
For Additional Information Contact kyra Schmitt
763-505-0237
Manufacturer Reason
for Recall		 Outer package of Lioresal Intrethecal Refill Kit, model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).
FDA Determined
Cause 2		 Other
Action Customers were contacted 11/19/04 via telephone. Customers were asked to set aside product and return the affected lot to Medtronic, Inc., Moundsview, MN. Recalled product will be replaced by Medtronic.
Quantity in Commerce 96 kits were distributed to 34 customers
Distribution within the United States only
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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