Tested AC Control BD — Class II medical device recall Z-0279-2013

Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-11-21, distributed nationwide. Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperat

Recall number	`Z-0279-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States
Recall initiated	2012-10-16
Classified	2012-11-13
Reported by FDA	2012-11-21
Terminated	2013-07-11
Distributed	Nationwide (US)
Quantity	15 units
Serial numbers	`824POOO023`, `831`, `831P001161`, `831P001164`, `836POOOO05`, `P001130`, `P001133`, `P001136`, `P001140`, `P001144`, `P001145`, `P001146`, `P001149`, `P001151`, `P001159`, `POO1141`
Model numbers	`817168`

Product

Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.

Reason for recall

Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0279-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.