Class 2 Device Recall BD MaxGuard Flow Controller Extension Set

• Date Initiated by Firm: August 01, 2022
• Date Posted: September 13, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1754-2022
• Recall Event ID: 90707
• 510(K)Number: K051499
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
• Code Information: UDI-DI: 10885403236358, Lots: 22019311, 22019312, 22019313, 22019314
• Recalling Firm/ Manufacturer: CAREFUSION; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
• FDA Determined Cause: Error in labeling
• Action: On 8/1/22 Correction-recall notices were emailed or mailed to customers and distributors who were asked to do the following: 1) Destroy affected devices following your institutions process for destruction. 2) Share this notification with all users within your facility network to ensure all are aware. The correction-recall notice should also be shared with any organization where the potentially affected product has been transferred. 3) Complete and return the response form. In addition distributors were informed that the recalling firm plans to notify all affected customers directly so they were asked to provide a a list of customers who received affected devices. The distributor response form has a check box if the distributor declines to provide a customer list to the recalling firm because they have notified customers about the correction-recall. A copy of the customer communication was provided to the distributor. If customers or distributors require additional assistance they are aske to call 1-844-823-5433, Mon-Fri 8:00 AM - 5:00 PM CT or productcomplaints@bd.com
• Quantity in Commerce: 54,050
• Distribution: US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FPA and Original Applicant = MEDEGEN MEDICAL MANUFACTURING SERVICES