Official recall notice

FDA DeviceClass INotable

Halyard Heart Cath Self Regional kit Recall (May 2026)

Product: Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.

Recall date
2026-05-13
FDA class
Class I

Why it was recalled

Hazard

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

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Product description

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Verify with the official notice →
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