Label From Busse Hospital Disposals

Busse Hospital Disposals has 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. 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 their facility and identified as affected may be destroyed following instructions on the recall letter.

The recalled Busse kits/trays were manufactured and distributed to medical device distributors from July 2022 to November 2023.

The following products (See Table Below), which contain Nurse Assist Part#6240, Stericare 100ML Sterile Saline Botle have been recalled.

Products can be identified by locating the information below on their respective labeling – see reference image above.

To date, Busse has not received any reports of serious injuries or deaths associated with this recall. Busse has notified both the FDA and affected distributors of the recall through direct communications. The company remains commited to ensuring the safety and well-being of their customers.

Source: FDA