Class 2 Device Recall Caresite

• Date Initiated by Firm: September 15, 2022
• Date Posted: October 14, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0092-2023
• Recall Event ID: 90850
• 510(K)Number: K942988 K083723
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
• Code Information: UDI-DI (GTIN): 04046964298691 Lots/Expiration Dates 61762215 15-Dec-23 61762791 22-Jan-24 61767369 26-Feb-24 61779625 7-Jun-24 61791895 11-Aug-24 61806047 4-Nov-24
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: BBMI Postmarket Surveillance Department; 833-425-1464
• Manufacturer Reason for Recall: The extension set has a high probability of potential failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
• FDA Determined Cause: Process design
• Action: On September 15, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine the product subject to recall. Once customers have returned the completed acknowledgement form to B. Braun Medical Inc., a Customer Support representative will contact the customer with instructions on returning impacted cases. The firm will provide credit and/or replacement of the product based on the customer's needs. For questions, please contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
• Quantity in Commerce: 354,200 US; 1,800 OUS
• Distribution: Distribution US nationwide, Canada and Saudi Arabia.
• 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 = B. BRAUN MEDICAL, INC.; 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN OF AMERICA, INC.