Z-2617-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- October 17, 2017
- Termination Date
- June 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 boxes (5/each)= 20 eaches
Product Description
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Reason for Recall
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Distribution Pattern
Canada
Code Information
Lot Number: 5210162 (UDI): H96560M7019951