B Braun Medical Inc: 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

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: 190,625 units Lot/code info: 1. Catalog Number: 490528; Primary UDI-DI: 04046955203284; Unit of Dose UDI-DI: 04046955203277; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490550; Primary UDI-DI: 04046955270347; Unit of Dose UDI-DI: 04046955270330; Expiration Date: Earliest Exp of Comp or 24mths. 3. Catalog Number: 490605; Primary UDI-DI: 04046955352876; Unit of Dose UDI-DI: 04046955352869; Expiration Date: Earliest Exp of Comp or 36mths. 4. Catalog Number: 490616; Primary UDI-DI: 04046955664696; Unit of Dose UDI-DI: 04046955664689; Expiration Date: Earliest Exp of Comp or 36mths. 5. Catalog Number: 490654; Primary UDI-DI: 04046955836369; Unit of Dose UDI-DI: 04046955836352; Expiration Date: Earliest Exp of Comp or 36mths.

UPC codes

04046955203284, 04046955203277, 04046955270347, 04046955270330, 04046955352876, 04046955352869, 04046955664696, 04046955664689, 04046955836369, 04046955836352

Source

Official record: FDA (Device enforcement) ↗

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