Recall Z-2132-2024— B Braun Medical Inc

Name: FDA recall Z-2132-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-17

Class II · Ongoing

Class II FDA medical device recall by B Braun Medical Inc, initiated 2024-05-17. It names one FDA 510(k) clearance: K860126. Product: Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260. Reason: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP..

Recalling firm: B Braun Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-05-17
Firm location: Breinigsville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K860126 — STIMUPLEX, NERVE STIMULATORBurron Medical Products, Inc.·cleared 1986-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.