AVID Medical, Inc.: Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
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
- AVID Medical, Inc.
- Product
- Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
- Reason / hazard
- Devices are not suitable for organ transplant.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of FL, GA and Puerto Rico.
- Recall initiated
- 2025-11-11
- Code info
- Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
- Product quantity
- 380 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 98060
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