Z-2632-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2023
- Initiation Date
- August 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3050 devices
Product Description
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Reason for Recall
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Thailand, United Kingdom.
Code Information
UDI-DI: 10884521013162, 20884521013169; Lot Numbers: 2221700131, 2224200233, 2230400271, 2230400272