FDA Device recall Z-0199-2022
The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an access…
- FDA Device
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an access… by Bayer Medical Care, citing labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0199-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-14 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bayer Medical Care |
| Distribution | US |
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
Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Identifiers
| code_info | Batch number: 8415317 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0199-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.