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

Recall Z-0420-2022 — Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

U.S. FDA — Device Enforcement · United States · 2021-11-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0420-2022
Date of alert
2021-11-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15414734008805
Reported risk: As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in 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.