B Braun Medical Inc: Extension 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. L

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: 43,452 units Lot/code info: 1. Catalog Number: 490448; Primary UDI-DI: 04046964848858; Unit of Dose UDI-DI: 04046964848841. Shelf Life: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490465; Primary UDI-DI: 04046964950735; Unit of Dose UDI-DI: 04046964950728. Shelf Life: Earliest Exp of Comp or 36mths. 3. Catalog Number: 490486; Primary UDI-DI: 04046964991257; Unit of Dose UDI-DI: 04046964991240. Shelf Life: Earliest Exp of Comp or 24mths. 4. Catalog Number: 490577; Primary UDI-DI: 04046955287536; Unit of Dose UDI-DI: 04046955287529. Shelf Life: Earliest Exp of Comp or 36mths.

UPC codes

04046964848858, 04046964848841, 04046964950735, 04046964950728, 04046964991257, 04046964991240, 04046955287536, 04046955287529

Source

Official record: FDA (Device enforcement) ↗

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