B Braun Medical Inc: SAFELINE 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. La

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: 46,250 units Lot/code info: 1. Catalog Number: 352604; Primary UDI-DI: 04046964181870; Unit of Dose UDI-DI: 04046964181863; Expiration Date: Earliest Exp of Comp or 60mths. 2. Catalog Number: NF1251; Primary UDI-DI: 04046964187100; Unit of Dose UDI-DI: 04046964187094; Expiration Date: Earliest Exp of Comp or 60mths. 3. Catalog Number: NF1290; Primary UDI-DI: 04046964187148; Unit of Dose UDI-DI: 04046964187131; Expiration Date: Earliest Exp of Comp or 60mths.

UPC codes

04046964181870, 04046964181863, 04046964187100, 04046964187094, 04046964187148, 04046964187131

Source

Official record: FDA (Device enforcement) ↗

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