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

Recall Z-0315-2024 — Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

U.S. FDA — Device Enforcement · United States · 2023-09-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0315-2024
Date of alert
2023-09-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ROi CPS LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10194717111702
Reported risk: Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
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.

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.