The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Me
FDA device recall Z-1384-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- Medtronic Inc, Neurological & Spinal Division
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LKK
- Quantity affected
- 405 kits
- Distribution
- US and one customer in New Zealand.
- Date initiated
- 2004-07-23
- Date posted
- 2004-08-24
- Date terminated
- 2005-11-23
- Location
- Columbia Heights, MN
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