Device product

Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

Z-2133-2024

May 17, 2024

Class II

Product summary

Firm: B Braun Medical Inc
Event: Event 94637
Status: Ongoing
Classification: Class II
Quantity: 108,811 units
Official record key: device-enforcement:Z-2133-2024

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: 4894278; UDI/DI: 04022495101266; Lot/Batch: 20E15, 21E18, 19F08, 19G10, 19G13, 19G19, 19I19, 20C28, 20C31, 20D10, 20L19, 21B13, 21I17, 21K21, 21L12, 21M16, 22D12, 22H20, 22I22, 22K27, 23A20, 23C04, 23D14, 23F09, 23I08, 23I29,

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.