Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
- Company
- Busse Hospital Disposables, Inc.
- Recall Initiated
- November 30, 2023
- Posted
- January 3, 2024
- Recall Number
- Z-0594-2024
- Quantity
- 240
- Firm Location
- Hauppauge, NY
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.
Lot / Code Info
UDI-DI 00849233011069 Lots 2210087 2210165 2310361
Root 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