Device product
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
Z-0329-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 72416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280 units
- Official record key
device-enforcement:Z-0329-2016
Official wording
Reason: Incorrectly packaged with a 90 degree bend at the distal tip
Code information: Lot Numbers: 1503500094, 1431900098, 1435800009
Distribution pattern: Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
Incorrectly packaged with a 90 degree bend at the distal tip