Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name:… — Class II medical device recall Z-0483-2021
Terminated recall by Bayer Medical Care, Inc., reported 2020-12-02, distributed nationwide. Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential
| Recall number | Z-0483-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Medical Care, Inc., Indianola, PA, United States |
| Recall initiated | 2020-10-05 |
| Classified | 2020-11-23 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2021-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 92,420 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00616258010656, 00616258022888 |
| Lot numbers | 8584324, 8585234, 8586383, 8586384, 8586385, 8586386, 8586388 |
| Model numbers | FLEXD-150-SCS, FLEXD-150-SPK |
Product
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.
Reason for recall
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0483-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.