Class 2 Device Recall Extension Set

• Date Initiated by Firm: October 29, 2025
• Date Posted: November 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0633-2026
• Recall Event ID: 97816
• 510(K)Number: K083723 K942988
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ B/C VALVE 53 in.; Catalog Number: 490358.
• Code Information: 1. Catalog Number: 490358; Primary UDI-DI: 04046964642746; Unit of Dose UDI-DI: 04046964642739.
• Recalling Firm/ Manufacturer: B Braun Medical Inc; 824 12th Ave; Bethlehem PA 18018-3524
• For Additional Information Contact: Allison Longenhagen; 001-484-2408373
• Manufacturer Reason for Recall: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• FDA Determined Cause: Process control
• Action: B Braun notified consignees on about 10/29/2025 via letter. Consignees were instructed to follow "Interim Measures for Users" as outlined in the letter for secondary infusions via gravity sets and if using secondary infusions with infusion pumps. Consignees were also instructed to inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where IV administration sets and pump administration sets may be stored until further notice. B. Braun will provide additional notification when users may resume their normal secondary administration process without the need for the modified workflow. Consider priming all IV administration sets and pump administration sets with normal saline or other standard solutions prior to priming with expensive medications to avoid loss of expensive medications or occupational exposure to hazardous medications in the event the set is unable to be primed. If difficulty priming is encountered, obtain a replacement device and file a customer complaint with B. Braun. Additionally, consignees were requested to ensure all pertinent employees and customers are informed, post the notification where affected products are stored, and complete and return the "Urgent Medical Device Correction Acknowledgement Form."
• Quantity in Commerce: 1,200 units
• Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
• 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