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

Recall Z-1219-2019 — CryoPatch SG Pulmonary Hemi-Artery Patch

U.S. FDA — Device Enforcement · United States · 2016-11-21 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1219-2019
Date of alert
2016-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CryoLife, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10685466
Reported risk: The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.