Z-2531-2025 Class II Ongoing

Recalled by AVID Medical, Inc. — Toano, VA

Recall Details

Product Type
Devices
Report Date
September 17, 2025
Initiation Date
August 4, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
228 units

Product Description

Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.

Reason for Recall

Potential for open header bag seals, compromising sterility.

Distribution Pattern

US Nationwide distribution in the state of Florida.

Code Information

Model Number: 1646381. UDI: 10809160363256. Lot Number: 1646381. Expiration Date: 1/31/2028.