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

Recall Z-1376-2021 — Regard, Item Number 830067009, custom cardiovascular procedure kit

U.S. FDA — Device Enforcement · United States · 2021-03-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1376-2021
Date of alert
2021-03-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ROi CPS LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
830067009
Reported risk: ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
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.