The Recall Desk
HighFDA (Devices)·Z-0199-2022·Announced 2021-11-10

MEDRAD Twist & Go Syringe Recalled Due to Labeling Error

Bayer Medical Care is recalling 6,950 units of MEDRAD Twist & Go Disposable Syringes due to labeling errors that could cause confusion about syringe compatibility with the MEDRAD Mark 7 Arterion Injection System.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a labeling error on a medical device accessory that could lead to improper product identification and use. Although no illnesses or injuries have been reported, the mislabeling of a device used in injection systems presents a risk of harm if users select the wrong syringe based on incorrect labeling.

Plain-English summary

Bayer Medical Care, Inc. is recalling 6,950 units of the MEDRAD Twist & Go Disposable Syringe (150 mL with Quick Fill Tube) due to a labeling error. Units are labeled as Twist & Go Syringes (TAG 150 SYR) when they should be labeled as Mark 7 Arterion Injection System Syringes (ART 700 SYR).

The labeling discrepancy could cause confusion about product identification and proper use with the MEDRAD Mark 7 Arterion Injection System injector. This syringe is designed as an accessory to be loaded into the injector head of the system.

The recalled syringes were distributed worldwide, including throughout the United States and to Australia, Belarus, Germany, Denmark, United Kingdom, Croatia, Netherlands, New Zealand, Russia, Sweden, and Thailand. The batch number is 8415317.

Healthcare providers using these syringes should verify they have the correct labeling (ART 700 SYR) and contact Bayer Medical Care for guidance on this issue.

The recalled product

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.
Manufacturer
Bayer Medical Care, Inc.
Category
Medical Device — Injection System Accessory
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batch number: 8415317

Distribution

Distributed nationwide across the United States.

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