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

Recall Z-1172-2018 — HEMASHIELD Knitted Double Velour Cardiovascular Fabric

U.S. FDA — Device Enforcement · United States · 2018-01-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1172-2018
Date of alert
2018-01-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GETINGE US SALES LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00384401017899
Reported risk: A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).
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.

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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.