B Braun Medical Inc — CARESAFE 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. Labe
⚠️ Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- October 29, 2025
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
What's affected?
- Product
- CARESAFE 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 numbers: 1. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310.
- Brand
- B Braun Medical Inc
- Lot code
- 1. Catalog Number: 354302; Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939. 2. Catalog Number: 354303; Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417. 3. Catalog Number: 354304; Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953. 4. Catalog Number: 354305; Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431. 5. Catalog Number: 354306; Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977. 6. Catalog Number: 354307; Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455. 7. Catalog Number: 354308; Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991. 8. Catalog Number: 354310; Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.
Additional details
1. Catalog Number: 354302; Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939. 2. Catalog Number: 354303; Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417. 3. Catalog Number: 354304; Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953. 4. Catalog Number: 354305; Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431. 5. Catalog Number: 354306; Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977. 6. Catalog Number: 354307; Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455. 7. Catalog Number: 354308; Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991. 8. Catalog Number: 354310; Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4,438 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.