Bayer Medical Care, Inc.: MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Bayer Medical Care, Inc.
- Product
- MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
- Reason / hazard
- Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-07-31
- Code info
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Product quantity
- 27800 kits (556 boxes)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Indianola
- State
- PA
- Country
- United States
- Event id
- 99698
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