Date Initiated by Firm | November 30, 2023 |
Date Posted | January 03, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0593-2024 |
Recall Event ID |
93546 |
Product Classification |
Wound dressing kit - Product Code MCY
|
Product | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE |
Code Information |
UDI-DI 00849233010727
Lots 2210077
2210112
2310275
2310331
|
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 | 536 |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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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