Bayer Recalls MEDRAD Stellant FLEX Syringe Kits Due to Cracks
Bayer Medical Care is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits because they may have holes or cracks that allow fluid to leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (cracks/holes) that poses a risk of harm (fluid leakage) during a procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bayer Medical Care, Inc. is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits. The affected products are angiographic syringe kits containing 150 mL FLEX syringes, spikes, and tubing. The recall involves 92,420 units distributed to healthcare facilities nationwide throughout the US.
The recall was initiated because the syringe kits may have holes and/or cracks. These defects have the potential to allow fluid to leak out of the syringe. The affected catalog numbers are FLEXD-150-SCS and FLEXD-150-SPK, with specific lot numbers and UDI numbers listed in the agency's recall record.
Healthcare facilities should stop using the affected syringe kits and contact Bayer Medical Care for instructions on how to return the products. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- 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…
- Manufacturer
- Bayer Medical Care, Inc.
- Affected units
- 92,420
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 8586383
- 8586384
- 8586385
- 8586386
Distribution
Distributed nationwide across the United States.
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