FDA recall Z-2131-2024

B Braun Medical Inc · Class II · device

Product

Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

Reason for recall

The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2024-05-17
Report date
2024-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Breinigsville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2024