FDA Device Recall Z-0594-2024

Busse Hospital Disposables, Inc. · Hauppauge, NY

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

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

Lot / serial / GTIN: UDI-DI 00849233011069 Lots 2210087 2210165 2310361

Quantity: 240

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.

Recall record

Recall number: Z-0594-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: US Nationwide distribution.
Recall initiated: 2023-11-30
Classified by FDA Center: 2024-01-03
FDA published: 2024-01-10
Recalling firm: Busse Hospital Disposables, Inc.
Firm location: Hauppauge, NY

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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