The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube… — Class II medical device recall Z-0199-2022
Terminated recall by Bayer Medical Care, Inc., reported 2021-11-10, distributed nationwide. Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes
| Recall number | Z-0199-2022 |
|---|---|
| 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 | 2021-09-14 |
| Classified | 2021-11-03 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2023-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 6,950 units |
| Reason classes | labeling |
| Lot numbers | 8415317 |
Product
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.
Reason for recall
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
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-0199-2022. 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.