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

20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. — recall Z-0733-2025

U.S. FDA — Device Enforcement · United States · 2024-11-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0733-2025
Date of alert
2024-11-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Vascular Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08717648015274
Reported risk: Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
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.