The Model 8540 Catheter Access Port Kit is intended for use… recallZ-1384-04 · Medtronic Inc, Neurological & Spinal Division · initiated Jul 23, 2004

Why it was recalled

The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.

FDA root cause category: Other

What the company is doing

The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of manufactured product: CS0293.

Recall details

Recall number

Z-1384-04

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jul 23, 2004

Posted by the FDA

Aug 24, 2004

Recalling firm

Medtronic Inc, Neurological & Spinal Division

Quantity

405 kits

Product code

LKK

FDA submissions

P860004

Distribution

US and one customer in New Zealand.

Product description

The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port 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