Home / Recalls / Bayer Medical Care, Inc. / Z-0199-2022

Z-0199-2022 Class II Terminated

Recalled by Bayer Medical Care, Inc. — Indianola, PA

Recall Details

Product Type
Devices
Report Date
November 10, 2021
Initiation Date
September 14, 2021
Termination Date
January 19, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6,950 units

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)

Distribution Pattern

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

Code Information

Batch number: 8415317

Other recalls by Bayer Medical Care, Inc.

  • Z-0910-2023 Class II — Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, (November 30, 2022)
  • Z-0483-2021 Class II — Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syrin (October 5, 2020)
  • Z-0745-2019 Class II — MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjuncti (December 14, 2018)
  • Z-0097-2019 Class II — Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administrati (September 7, 2018)
  • Z-2961-2018 Class II — Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Ba (June 28, 2018)
  • Z-2960-2018 Class II — Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalo (June 28, 2018)
  • Z-2962-2018 Class II — Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalo (June 28, 2018)