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Open, Classified

Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

FDA Recall Z-0594-2024 · Posted 2024-01-03

Recalling FirmBusse Hospital Disposables, Inc.
Recall StatusOpen, Classified
Product CodeNXA
Date Initiated2023-11-30
Product Quantity240

Reason for Recall

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.

Firm Action

On November 21, 2023, the firm notified affected distributors via URGENT MEDICAL DEVICE RECALL letters. Customers were asked to segregate and destroy any affected kits. Distributors should also inform their customers of the recall. Customers should return any affected product to their distributor. For questions, email [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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