FDAFDA · Food and drugs·Recall number Z-2133-2024
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Published June 19, 2024 · Recall initiated: May 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- B Braun Medical Inc
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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