FDA DeviceClass INotable

FDA Recall: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

Date: 2026-05-13
Brand: AVID Medical, Inc.
Category: Medical Device
FDA Class: Class I

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.

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.

Remedy

222 kits

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