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U.S. Department of Health and Human Services

Class 1 Device Recall DRESSING CHANGE TRAY / STERILE LATEX FREE

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  Class 1 Device Recall DRESSING CHANGE TRAY / STERILE LATEX FREE see related information
Date Initiated by Firm November 30, 2023
Date Posted January 03, 2024
Recall Status1 Open3, Classified
Recall Number Z-0594-2024
Recall Event ID 93546
Product Classification Tracheotomy care kit - Product Code NXA
Product Catalog No. 9251R1, 9251R2, 9251R3
TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Code Information UDI-DI 00849233011069 Lots 2210087 2210165 2310361
Recalling Firm/
Manufacturer		 Busse Hospital Disposables, Inc.
75 Arkay Dr
Hauppauge NY 11788-3707
For Additional Information Contact Clarissa Sabillon
631-435-4711 Ext. 2200
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 NurseAssistRecall@busseinc.com
Quantity in Commerce 240
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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