Z-2296-2026Class II

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta...

Name: Z-2296-2026 Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta...
Creator: Bayer Medical Care, Inc.
Published: 2026-04-24
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2026-04-24 / Open, Classified / root cause: manufacturing process

FDA source

Bayer Medical Care, Inc. began a recall of 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... on 2026-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2296-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-24
Posted: 2026-06-03
Recalling firm: Medrad, 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;
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On April 24, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Customers were instructed to immediately halt the use of the affected product and review inventory for impacted product and quarantine. A Return Goods Authorization will be sent to return any remaining affected inventory. Place the affected product in a box and label the outside of the container with the RGA number provided and RECALL ID: SA-2026-RAD-03 in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return the affected product as soon as possible. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.
Quantity in commerce: 11,300 units (1650 US, 9650 OUS)
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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2296-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2296-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03

Product code DXT

K050456Class IIMedrad Avanta Fluid Management Injection SystemMedrad, Inc. / cleared 2005-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)