FDA Announces Busse Hospital Disposables’ Recall of Care Trays and Sets Containing Sterile Water–Based Products
On December 20, 2023, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based) that Busse Hospital Disposables, Inc., had recalled its tracheostomy care tray, dressing change tray, and tracheostomy care set. Busse’s recall is in direct response to Nurse Assist LLC’s, November 6, 2023, recall of its 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns, which is the only saline used in the Busse trays and kits. The recall doesn't apply to the other kit components. FDA identified (https://www.fda.gov/medical-devices/medical-device-recalls/busse-hospital-disposables-inc-recalls-care-trays-and-kits-containing-sterile-water-based-products) it as a class I recall, where use of the devices may cause serious injuries or death.
The recall affects Busse’s tracheostomy care tray (catalog no. 800) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204700), dressing change tray (catalog no. 1443) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204701), and tracheostomy care set (catalog nos. 9251r1, 9251r2, 9251r3) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=204702). A total of 1,706 devices containing the recalled Nurse Assist 0.9% sodium chloride irrigation USP and sterile water for irrigation USP were distributed in the United States from June 20, 2022–November 7, 2023. Busse initiated (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based) its recall on November 21, 2023.
FDA said (https://www.fda.gov/medical-devices/medical-device-recalls/busse-hospital-disposables-inc-recalls-care-trays-and-kits-containing-sterile-water-based-products) that the “use of the affected devices may cause serious adverse health consequences, including blood stream infections, urinary tract or respiratory infections, and in the worst-case scenario, sepsis and death.” Individuals with decreased immune systems, such as from cancer treatment, or are otherwise susceptible to infection or chronic lung diseases, may have increased risk. However, to date FDA has not received any reports of injury or death.
On November 21, 2023, and December 6, 2023, Busse Hospital Disposables sent two urgent medical device recall notices that requested all affected customers to:
- Destroy devices that have been shipped directly to customer facilities and identified as affected.
- Use the form provided with the letter to document the quantity of the destroyed product(s) and provide a photograph of the items clearly displaying the lot number, then submit the information to Nurse Assist and send a copy to Busse.
- Complete and submit to Busse the included acknowledgement and receipt form, regardless of whether they had the affected product.
U.S. customers with questions about this recall should contact Busse Hospital Disposables at 800-645-6526. Healthcare professionals and consumers may report (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Additional FDA Resources:
- Recall of Certain Saline and Sterile Water Medical Products Associated With Nurse Assist: FDA Safety Communication (https://www.fda.gov/medical-devices/safety-communications/recall-certain-saline-and-sterile-water-medical-products-associated-nurse-assist-fda-safety)
- Busse Hospital Disposables Issues Nationwide Recall of Kits/Trays Containing Sterile Water Based Products Under Recall by Nurse Assist (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/busse-hospital-disposables-issues-nationwide-recall-kitstrays-containing-sterile-water-based)