B Braun Medical Inc: ADDitIV 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

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: 43,900 units Lot/code info: 1. Catalog Number: V1443; Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447; Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448; Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. 4. Catalog Number: V1484; Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466.

UPC codes

04046964188350, 04046964188343, 04046964188411, 04046964188404, 04046964188435, 04046964188428, 04046964188473, 04046964188466

Source

Official record: FDA (Device enforcement) ↗

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