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. Labele

Hazard

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

Details from the source

Reason for recall: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 4,438 units Lot/code info: 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.

UPC codes

04046955259946, 04046955259939, 04046955052424, 04046955052417, 04046955259960, 04046955259953, 04046955052448, 04046955052431, 04046955259984, 04046955259977, 04046955052462, 04046955052455, 04046955260003, 04046955259991, 04046955052929, 04046955052905

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.