Model 8561 Lioresal (Baclofen injection) Intrathecal Refill… recallZ-0391-05 · Medtronic Inc, Neurological & Spinal Division · initiated Nov 19, 2004

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number

Z-0391-05

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Nov 19, 2004

Posted by the FDA

Jan 13, 2005

Recalling firm

Medtronic Inc, Neurological & Spinal Division

Quantity

96 kits were distributed to 34 customers

Product code

LKK

FDA submissions

P860004

Distribution

within the United States only

Product description

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.

Other devices under the same FDA submission

51 devices cleared under P860004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• SYNCHROMED® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall7 deaths4,929 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls5 deaths4,303 reports
• SYNCHROMED ® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall6 deaths4,119 reports
• SYNCHROMED® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls10 deaths3,054 reports
• SYNCHROMED ® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall4 deaths3,084 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls1 death2,588 reports
• SynchroMed® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall6 deaths2,291 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 recall3 deaths2,242 reports
• SYNCHROMED® II 8637-40

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 recall4 deaths1,964 reports
• SynchroMed® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall4 deaths1,920 reports
• SYNCHROMED™ III 8667-20

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 death1,937 reports
• SYNCHROMED ® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 deaths1,766 reports