—#216887

Product

IV Administration 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. US1295 ULTRASITE IV ADMIN SET 60DROP; Catalog Number: 352394.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K022895, K032393
Affected lot / code info: 1. Catalog Number: 352394; Primary UDI-DI: 4046964293375; Unit of Dose UDI-DI: 04046964293368.

Why it was recalled

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Root cause (FDA determination)

Process control

Action the firm took

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."

Recalling firm

Firm: B Braun Medical Inc
Address: 824 12th Ave, Bethlehem, Pennsylvania 18018-3524

Distribution

Distribution pattern: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Timeline

Recall initiated: 2025-10-29
Posted by FDA: 2025-11-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216887. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.