FDA recall Z-1605-2023

Access Vascular, Inc · Class II · device

Product

HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

Reason for recall

The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

Distribution

US distribution to States of: FL, TN, TX.

Key facts

Status
Ongoing
Initiation date
2023-03-03
Report date
2023-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1605-2023