Bayer Medical Care Recalls Stellant FLEX Syringe Kits Due to Sterilization Issues
Bayer Medical Care is recalling 27,800 Stellant FLEX Syringe Kits because some may not have been properly sterilized due to a manufacturing issue.
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 risk-of-harm product (improper sterilization of medical devices) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Bayer Medical Care, Inc. is recalling 27,800 kits (556 boxes) of MEDRAD Stellant FLEX Syringe Kits used with the Stellant FLEX CT Injection System. The recall involves catalog number FLEXS-150-QFT, UDI-DI 00616258022895, affected material number 87078825, and affected batch number 8688750.
The recall was initiated because some devices may not have been properly sterilized due to a manufacturing sterilization issue. The affected products were distributed nationwide in the United States.
Consumers and healthcare facilities should stop using the affected syringe kits and contact Bayer Medical Care, Inc. for further instructions or a replacement.
The recalled product
- Product
- MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
- Manufacturer
- Bayer Medical Care, Inc.
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)
- Catalog number: FLEXS-150-QFT
- UDI-DI: 00616258022895
- Affected material number: 87078825
- Affected batch number: 8688750
Distribution
Distributed nationwide across the United States.
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