B Braun Medical Inc: ULTRASITE 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: 41,400 units Lot/code info: 1. Catalog Number: 352049-C; Primary UDI-DI: 04046964717666; Unit of Dose UDI-DI: 04046964717659; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: 375100-C; Primary UDI-DI: 04046964717680; Unit of Dose UDI-DI: 04046964717673; Expiration Date: Earliest Exp of Comp or 60mths.

UPC codes

04046964717666, 04046964717659, 04046964717680, 04046964717673

Source

Official record: FDA (Device enforcement) ↗

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