FDA Medical Device Recalls (openFDA)
B Braun Medical Inc: 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/ ULTRAPORT, 48 IN.; Catalog Number: 490291.
- Recall number
- Z-0634-2026
- Recalling firm
- B Braun Medical Inc
- 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/ ULTRAPORT, 48 IN.; Catalog Number: 490291.
- Status
- Open, Classified
- Initiated
- 2025-10-29
- Posted
- 2025-11-26
- Terminated
- not on file
- Reason
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Root 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
- 23,650 units
- Distribution
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Lot, serial or model codes
- 1. Catalog Number: 490291; Primary UDI-DI: 04046964716768; Unit of Dose UDI-DI: 04046964716751.
- 510(k) numbers
- ["K942988"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2521402
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28