Reported Dec 2, 2020 · Terminated
Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS…
Bayer Medical Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bayer Medical Care, Inc. · 1 Bayer Dr · Indianola, PA · 15051-9702
Is this the product you have?
- Brand NameMEDRAD
- Stellant FLEX Syringe Kits Common NameAngiographic
- Syringe Catalog/REF NumberFLEXD-150-SCS
- Description
2 - 150 mL FLEX syringes1 large saline spike1 small contrast spikepatient t-connector tubing & prime tube
- Catalog/REF NumberFLEXD-150-SPK
- Description
2 - 150 mL FLEX syringes2 small spikespatient t-connector tubing & prime tube
- Lot codes and dates
- Catalog/REF NumberFLEXD-150-SCS
- Material Number87078817
- Lot Numbers
858432485863838586384858638585863868586388
- 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 NumberFLEXD-150-SPK
- Material Number85020218
- Lot Number8585234
- UDI Numbers(01)00616258010656(11)200720(17)240720(10)8585234
- Amount recalled
- 92,420 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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