Z-2131-2024 Class II Ongoing
FDA device recall Z-2131-2024 was initiated by B Braun Medical Inc on May 17, 2024 and is designated Class II. Reason for recall: The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP. The recall status is ongoing. Affected quantity: 20,850 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2024
- Initiation Date
- May 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,850 units
Product Description
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
Reason for Recall
The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
Catalogue Number: 4894251; UDI/DI: 04022495101167; Lot/Batch: 20E15, 19L09, 19L27, 20A19, 20H21, 21G14, 21I16, 22H23,
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2131-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026