Z-0648-2026Class II
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with...
B Braun Medical Inc / initiated 2025-10-29 / Open, Classified / root cause: manufacturing process
B Braun Medical Inc began a recall of IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook... on . FDA classified it as Class II and gives the reason as "Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion)". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0648-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- B Braun Medical Inc
- 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. IV ANES 15DROP W/2 CARESITE ULTRAPORT; Anesthesia IV Set with 2 CARESITE injection sites and high-flow ULTRAPORT stopcock; Catalog Number: 354209. 2. IV ADMIN SET W/60 DROPS/ML 106 IN.; Catalog Number: 490392. 3. IV ADMIN SET W/ 60 DROPS/ML 120 IN.; Catalog Number: 490428.
- Product code
- FMG Stopcock, I.V. Set
- Reason for recall
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Root cause tag
- manufacturing process
- FDA 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 in commerce
- 89,552 units
- Distribution
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Product codes and lots
- 1. Catalog Number: 354209; Primary UDI-DI: 04046964182150; Unit of Dose UDI-DI: 04046964182143. 2. Catalog Number: 490392; Primary UDI-DI: 04046964737367; Unit of Dose UDI-DI: 04046964737350. 3. Catalog Number: 490428; Primary UDI-DI: 04046964823541; Unit of Dose UDI-DI: 04046964823534.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0603-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0604-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0605-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0606-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0607-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0608-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0609-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0610-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0611-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0612-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0613-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0614-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0615-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0616-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0617-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0618-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0619-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0620-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0621-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0622-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0623-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0624-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0625-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0626-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0627-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0628-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0629-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0630-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0631-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0632-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0633-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0634-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0635-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0636-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0637-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0638-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0639-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0640-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0641-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0642-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0643-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0644-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0645-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0646-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0647-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0648-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0649-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0650-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0651-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0652-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0653-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0654-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0655-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0656-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0657-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0658-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0659-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0660-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0661-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0662-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0663-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0664-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0665-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0666-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0667-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0668-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0669-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0670-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0671-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0672-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0673-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0674-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0675-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0676-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0677-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0678-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0679-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0680-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0681-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0682-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0683-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0684-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0685-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0686-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0687-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0688-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0689-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0690-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0691-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0692-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0693-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0694-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0695-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0696-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0697-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0698-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0699-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0700-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0701-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0702-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0703-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0704-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0705-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0706-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0707-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0708-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0709-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0710-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0711-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0712-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0713-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0714-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0715-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0716-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0717-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0718-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.