Bayer Medical Care, Inc. recalls Avanta Multi-Patient Administration Tube Sets

Recalling company

Bayer Medical Care, Inc.

Product

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

Reason

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Apr 24, 2026

Reported

Jun 10, 2026

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.

Status

Ongoing

Quantity

11,300 units (1650 US, 9650 OUS)

Lot / codes

Catalog number: AVA 500 MPAT (Part 2 of 2) Affected material numbers: 87629007, 60729458, 86566648; Affected batch numbers: 251702, 252302, 252502, 252602, 252702, 252802, 253304, 253702, 253704, 253804, 254202, 254304, 254704, 254802;

Company location

Indianola, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-2296-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2296-2026 in the FDA Enforcement Report. Also see FDA recall press releases.