Recall Z-0199-2022— Bayer Medical Care, Inc.
Class II · Terminated
Class II FDA medical device recall by Bayer Medical Care, Inc., initiated 2021-09-14, terminated 2023-01-19. It names one FDA 510(k) clearance: K132928. 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).
- Recalling firm
- Bayer Medical Care, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-14
- Terminated
- 2023-01-19
- Firm location
- Indianola, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.