RecallRadar

FDA Device recall Z-2134-2024

Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

On 2024-06-19 the FDA classified a Class II recall of Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 by B Braun Medical, citing the devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2134-2024
ClassificationClass II
Statusongoing
Initiated2024-05-17
Published2024-06-19
Last updated2026-09-13 11:57 UTC
CompanyB Braun Medical
DistributionUS

Product

Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

Reason

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

Identifiers

code_info
Catalogue Number: 4894502; UDI/DI: 04022495101310; Lot/Batch: 20E01, 20E03, 21E07, 21E09, 19E10, 22E10, 22E11, 21E13, 2…Catalogue Number: 4894502; UDI/DI: 04022495101310; Lot/Batch: 20E01, 20E03, 21E07, 21E09, 19E10, 22E10, 22E11, 21E13, 20E19, 20E20, 19E21, 19E22, 20E22, 23E26, 20E27, 23E31, 19F12, 19F13, 19F15, 19G03, 19G04, 19G06, 19G09, 19G20, 19G21, 19G24, 19G25, 19G27, 19H23, 19H28, 19H30, 19I11, 19I21, 19I25, 19I26, 19K11, 19K16, 19K17, 19K24, 19K25, 19L12, 19L13, 19L15, 19L19, 19M12, 19M14, 19M17, 19M21, 19M24, 19M26, 20A30, 20A31, 20B15, 20B18, 20B19, 20B21, 20B26, 20B27, 20C14, 20C17, 20C18, 20D01, 20D02, 20D04, 20D14, 20D16, 20D17, 20D21, 20D29, 20F06, 20F10, 20F11, 20F12, 20F13, 20G21, 20G22, 20G23, 20G29, 20G31, 20H01, 20H05, 20H26, 20H27, 20H29, 20L27, 20L28, 20M03, 20M19, 20M23, 20M25, 20M26, 21A16, 21A19, 21B04, 21B06, 21B10, 21B18, 21B20, 21B25, 21C11, 21C13, 21C17, 21D07, 21D08, 21D10, 21D29, 21F19, 21F23, 21F24, 21F25, 21F26, 21F30, 21G08, 21G09, 21G10, 21G14, 21G17, 21G20, 21G21, 21H05, 21H06, 21H07, 21H26, 21H28, 21I04, 21I22, 21I26, 21K07, 21K09, 21K13, 21K29, 21K30, 21L16, 21L17,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2134-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.