Device product

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.

Z-0483-2021

October 05, 2020

Class II

Product summary

Firm: Bayer Medical Care, Inc.
Event: Event 86619
Status: Terminated
Classification: Class II
Quantity: 92,420 units
Official record key: device-enforcement:Z-0483-2021

Official wording

Reason: 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.

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

Distribution pattern: Distributed to healthcare facilities nationwide throughout the US.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.