Recall Z-0593-2024
Busse Hospital Disposables, Inc. · initiated November 30, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Codes / lots: UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331
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: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0593-2024
- Initiated
- November 30, 2023
- Posted by FDA
- January 3, 2024
- Product code
- MCY – Wound Dressing Kit
- Quantity
- 536
- Distribution
- US Nationwide distribution.
- Recalling firm
- Busse Hospital Disposables, Inc., Hauppauge, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0592-2024 Class I | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREEFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist… | 11/30/2023Open, Classified |
| Z-0594-2024 Class I | Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREEFirm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist… | 11/30/2023Open, Classified |