FDA recall Z-0025-2024

Becton Dickinson Infusion Therapy Systems Inc. · Class II · device

Product

REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

Reason for recall

There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.

Distribution

US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.

Key facts

Status
Ongoing
Initiation date
2023-08-29
Report date
2023-10-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sandy, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0025-2024