FDA Enforcement
Class II
Ongoing
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
Recall: Z-2131-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2131-2024
- 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, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
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: 4894251; UDI/DI: 04022495101167; Lot/Batch: 20E15, 19L09, 19L27, 20A19, 20H21, 21G14, 21I16, 22H23,
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Quantity
20,850 units