Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Spa
FDA device recall Z-0634-2026 · posted 2025-11-26 · Open, Classified
Recall details
- Recalling firm
- B Braun Medical Inc
- Reason for recall
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Action taken
- 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."
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 23,650 units
- Distribution
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Date initiated
- 2025-10-29
- Date posted
- 2025-11-26
- Location
- Bethlehem, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FILTERED EXTENSION SETS (K942988) | B. Braun of America, Inc. | 1995-07-14 |