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Recall Observatory FDA recall evidence

Device product

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

Z-2131-2024

May 17, 2024

Class II

Product summary

Firm
B Braun Medical Inc
Event
Event 94637
Status
Ongoing
Classification
Class II
Quantity
20,850 units
Official record key
device-enforcement:Z-2131-2024

Official wording

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

Code information: Catalogue Number: 4894251; UDI/DI: 04022495101167; Lot/Batch: 20E15, 19L09, 19L27, 20A19, 20H21, 21G14, 21I16, 22H23,

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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