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

Recall Z-0594-2024 — Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

U.S. FDA — Device Enforcement · United States · 2023-11-30 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0594-2024
Date of alert
2023-11-30
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Busse Hospital Disposables, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00849233011069
Reported risk: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
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.