FDA recall Z-2617-2021

Product

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

Canada

Key facts

Status

Terminated

Initiation date

2017-10-17

Report date

2021-10-06

Termination date

2022-06-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glens Falls, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2021