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.
Reported: December 2, 2015 Initiated: October 14, 2015 #Z-0329-2016
Product Description
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.
Reason for Recall
Incorrectly packaged with a 90 degree bend at the distal tip
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- 280 units
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Covidien LLC. Units affected: 280 units.
Why was this product recalled? ▼
Incorrectly packaged with a 90 degree bend at the distal tip
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2015. Severity: Moderate. Recall number: Z-0329-2016.
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