Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Summary
The FDA issued a Class I for Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE by Busse Hospital Disposables, Inc.. Reason: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for wh.
Details
Source
Device Recall
External ID
Z-0592-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
Product Description
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Lot/Code Info: UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
Quantity Affected: 705
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-30
Company
Hauppauge, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 84 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Busse Hospital Disposables, Inc. has 63 FDA actions in our database, including 63 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Busse Hospital Disposables, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Busse Hospital Disposables, Inc. have FDA actions?
Busse Hospital Disposables, Inc. has 63 FDA actions in our database, including 63 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0592-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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