Z-0330-2016 Class II Terminated
FDA device recall Z-0330-2016 was initiated by Covidien LLC on Oct 14, 2015 and is designated Class II. Reason for recall: Incorrectly packaged with a 90 degree bend at the distal tip The recall status is terminated (terminated Jun 2, 2017). Affected quantity: 160 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 2, 2015
- Initiation Date
- Oct 14, 2015
- Termination Date
- Jun 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 units
Product Description
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P 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
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
Code Information
Lot Numbers: 1500600182 ,1423000104
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0330-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026