Product Wiki · Recalls · U.S. FDA — Device Enforcement

Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease. — recall Z-2251-2016

U.S. FDA — Device Enforcement · Canada · 2016-05-06 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2251-2016
Date of alert
2016-05-06
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
BEST THERATRONICS LTD.
Product category
device
Product type
Devices
Reported risk: It was discovered that both the new device and the predicate device failed to comply with performance standard.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.