B Braun Medical Inc: Infusomat 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. Label

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: 49,330,370 Lot/code info: 1. Catalog Number: 362032; Primary UDI-DI: 04046964182556; Unit of Dose UDI-DI: 04046964182549. Shelf Life: Earliest Exp of Comp or 60mths. 2. Catalog Number: 362033; Primary UDI-DI: 04046964837821; Unit of Dose UDI-DI: 04046964837814. Shelf Life: Earliest Exp of Comp or 36mths. 3. Catalog Number: 362034; Primary UDI-DI: 04046964182570; Unit of Dose UDI-DI: 04046964182563. Shelf Life: Earliest Exp of Comp or 48mths. 4. Catalog Number: 362043; Primary UDI-DI: 04046964182631; Unit of Dose UDI-DI: 04046964182624. Shelf Life: Earliest Exp of Comp or 60mths. 5. Catalog Number: 362050; Primary UDI-DI: 04046964182655; Unit of Dose UDI-DI: 04046964182648. Shelf Life: Earliest Exp of Comp or 60mths. 6. Catalog Number: 362420; Primary UDI-DI: 04046955592715; Unit of Dose UDI-DI: 04046955592708. Shelf Life: 36mths from Start Date. 7. Catalog Number: 362431; Primary UDI-DI: 04046964294013; Unit of Dose UDI-DI: 04046964294006. Shelf Life: Earliest Exp of Comp or 60mths. 8. Catalog Number: 362432; Primary UDI-DI: 04046964182679; Unit of Dose UDI-DI: 04046964182662. Shelf Life: Earliest Exp of Comp or 60mths. 9. Catalog Number: 363010; Primary UDI-DI: 04046964294174; Unit of Dose UDI-DI: 04046964294167. Shelf Life: Earliest Exp of Comp or 48mths. 10. Catalog Number: 363019; Primary UDI-DI: 04046964294198; Unit of Dose UDI-DI: 04046964294181. Shelf Life: Earliest Exp of Comp or 60mths. 11. Catalog Number: 363030; Primary UDI-DI: 04046964294259; Unit of Dose UDI-DI: 04046964294242. Shelf Life

UPC codes

04046964182556, 04046964182549, 04046964837821, 04046964837814, 04046964182570, 04046964182563, 04046964182631, 04046964182624, 04046964182655, 04046964182648, 04046955592715, 04046955592708, 04046964294013, 04046964294006, 04046964182679, 04046964182662, 04046964294174, 04046964294167, 04046964294198, 04046964294181, 04046964294259, 04046964294242, 04046964294495, 04046964294488, 04046964294570, 04046964294563, 04046964294594, 04046964294587, 04046964294617, 04046964294600, 04046964294631, 04046964294624, 04046964294655, 04046964294648, 04046964837906, 04046964837890, 04046964294679, 04046964294662, 04046964837920, 04046964837913

Source

Official record: FDA (Device enforcement) ↗

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