Home / Recalls / Bayer Medical Care, Inc. / Z-0483-2021

Z-0483-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 2, 2020
Initiation Date
October 5, 2020
Termination Date
March 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92,420 units

Product Description

Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

Reason for Recall

Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.

Distribution Pattern

Distributed to healthcare facilities nationwide throughout the US.

Code Information

Catalog/REF Number: FLEXD-150-SCS Material Number: 87078817 Lot Numbers: 8584324, 8586383, 8586384, 8586385, 8586386, 8586388 UDI Numbers: (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 (01)00616258022888(11)200620(17)240620(10)8584324 Catalog/REF Number: FLEXD-150-SPK Material Number: 85020218 Lot Number: 8585234 UDI Numbers: (01)00616258010656(11)200720(17)240720(10)8585234

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-0199-2022 Class II — The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syring (September 14, 2021)
  • 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)