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

PET Infusion Pump — recall Z-0400-2017

U.S. FDA — Device Enforcement · United States · 2016-09-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0400-2017
Date of alert
2016-09-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bayer Healthcare
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20110777
Reported risk: The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.
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.

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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.