FDA Enforcement
Class II
Ongoing
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Recall: Z-2133-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2133-2024
- Event ID
- 94637
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- B Braun Medical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2024
- Initiation Date
- May 17, 2024
- Classification Date
- June 11, 2024
- Address
- 200 Boulder Dr, N/A, Breinigsville, PA, 18031-1532, United States
Description
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
Reason
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Code Info
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
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
108,811 units