Bayer Medical Care, Inc.: 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,

Is my product affected?

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 FL

• UPC 00616258022888
• UPC 00616258010656

Check against the official notice below — it lists the full affected range.

What happened

Bayer Medical Care, Inc. is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits used for angiographic procedures. The recalled kits may contain holes and/or cracks that could allow fluid to leak from the syringe. A total of 92,420 units were distributed to healthcare facilities nationwide across the United States, affecting multiple lot numbers: 8584324, 8586383, 8586384, 8586385, 8586386, 8586388, and 8585234.

The recall notice does not specify a remedy or recommended action for affected consumers or healthcare facilities.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: Distributed to healthcare facilities nationwide throughout the US. Quantity: 92,420 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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