FDA recall Z-1293-2024

Retractable Technologies, Inc. · Class II · device

Product

EasyPoint Needle, 25G x 5/8", REF: 82091

Reason for recall

The needle cannula of a retractable needle may detach from the needle holder in the patient.

Distribution

US Nationwide distribution including in the states of NY, FL, IL, MA, UT, NJ, AZ, MO, WA, NC, CA, TX, NV, IN, PA, VA, IA, GA, TN, MI, OH, OK, CO, OR, SC, MN, CT.

Key facts

Status
Ongoing
Initiation date
2024-02-05
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Elm, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1293-2024