United States
On November 21, 2023, Busse Hospital Disposals initiated a nationwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse initiated this recall in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility assurance, which could result in a nonsterile product. To date, Busse has not received any reports of serious injuries or deaths associated with this recall.
In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.
All distributors who are affected have been identified and notified through recall letters. The devices that have been shipped to your facility and identified as affected may be destroyed following instructions on the recall. The recalled Busse kits/trays were manufactured and distributed to medical device distributors from July 2022 to November 2023.
The following products, which contain Nurse Assist Part#6240, Stericare 100ML Sterile Saline Botle have been recalled:
- Catalog Number: 800, Product Description: Tracheostomy Care Tray – Sterile – Latex Free UDI: (01)00849233010000, Lot Numbers: (2210099, 2210135, 2210337, 2210377, 2310181, 2310233, 2310291)
- Catalog Number: 1443, Product Description: Dressing Change Tray – Sterile – Latex Free UDI: (01)00849233010727, Lot Numbers: (2210077, 2210112, 2310275, 2310331)
- Catalog Number: 9251R1, Product Description: Tracheostomy Care Set – Sterile – Latex Free UDI: (01)00849233011069, Lot Numbers: (2210087, 2210165, 2310361)
Products can be identified by locating the information above on their respective labeling.
Busse has notified both the FDA and affected distributors of the recall through direct communications. We remain commited to ensuring the safety and well-being of our customers.
In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Company name: Busse Hospital Disposals
Brand name: Busse Hospital Disposals
Product recalled: Medical Device Kits and Trays
Reason of the recall: Device & Drug Safety - Potential Lack of Sterility
FDA Recall date: December 20, 2023
Source:
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based
