Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
FDA device recall Z-0593-2024 · posted 2024-01-03 · Open, Classified
Recall details
- Recalling firm
- Busse Hospital Disposables, Inc.
- 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.
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MCY
- Quantity affected
- 536
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-11-30
- Date posted
- 2024-01-03
- Location
- Hauppauge, NY
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