CLASS II Device recall · Reported 10 Nov 2021 · FDA Enforcement Report

The Medrad Twist & Go Disposable Syringe recalled by Bayer Medical Care

Bayer Medical Care is recalling The Medrad Twist & Go Disposable Syringe with Quick Fill Tube is a syringe made from a, distributed nationwide in the US. The recall was initiated on 14 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch number: 8415317

Quantity recalled6,950 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0199-2022
FDA event ID: 88807
Recalling firm: Bayer Medical Care, Indianola, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Sep 2021
FDA classified: 3 Nov 2021
Reported: 10 Nov 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Syringes & Needles

Timeline

14 Sep 2021	Recall initiated by company
3 Nov 2021	Classified by FDA	+50 days
10 Nov 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Delaware

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Batch number: 8415317

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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