Z-2296-2026Class II

Bayer Medical Care, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-06-10

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.

Firm state

Product quantity

11,300 units (1650 US, 9650 OUS)

Initiated by

Voluntary: Firm initiated

Reason for recall

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.

Product description

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;

Code / lot info

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;

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →