Bayer Medical Care, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →