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Recall Observatory FDA recall evidence

Device 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.

Z-0199-2022

September 14, 2021

Class II

Product summary

Firm
Bayer Medical Care, Inc.
Event
Event 88807
Status
Terminated
Classification
Class II
Quantity
6,950 units
Official record key
device-enforcement:Z-0199-2022

Official wording

Reason: Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)

Code information: Batch number: 8415317

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling error