Class 2 Device Recall Infusomat

• Date Initiated by Firm: June 17, 2024
• Date Posted: July 17, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2404-2024
• Recall Event ID: 94823
• 510(K)Number: K140311 K913661
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
• Code Information: UDI-DI 04046955275588; All Lots Distributed After 22AUG2023.
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Allison Longenhagen; 001-484-2408373
• Manufacturer Reason for Recall: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
• FDA Determined Cause: Process control
• Action: B. Braun Medical Inc. (BBMI) is issuing a voluntary Urgent Medical Device Correction letter via US Postal Service Certified Mail with registered return receipt on 6/17/24. Letter states reason for recall, health risk and action to take: Corrective actions are being implemented to prevent these concerns in future manufacturing lots through optimization of the disks that provide the sealing function within these valves. Until such time as lots with these corrective actions are available, users are asked to follow the "Interim Measures for Users." A follow-up communication will be provided to users when lots with these corrective actions are in place and the interim measures can be stopped. At this time, we anticipate that corrected sets may become available 04 2024, but more definitive information will be provided in our follow-up notice. Interim Measures for Users: 1. Until further notice, when administering secondary medications via piggyback please clamp the primary line above the upper Y site using the available slide clamp on the pump administration set. This will require unclamping of the primary line after delivery of the secondary medication. The instructions for this differ depending on the type of pump and software as outlined below : a. Attachment 1 provides workflow recommendations for lnfusomat Space Pumps with "U" software versions. b. Attachment 2 provides workflow recommendations for lnfusomat Space Pumps with "G" software versions and "L" (Canada only) software versions. c. Attachment 3 provides workflow recommendations for Outlook ES Pumps. Note: This does not change workflows for rates of infusion greater than 300 ml/hr for lnfusomat Pump Administration Sets and 125 ml/hr with Outlook Pump Administration sets where clamping of the primary infusion line is always required per the product IFU to prevent concurrent flow. 2. Inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where pu
• Quantity in Commerce: 2352 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• 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; 510(K)s with Product Code = FPA