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 Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108 IN.; Catalog Number: 490504.

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Code information: 1. Catalog Number: 490504; Primary UDI-DI: 04046955135738; Unit of Dose UDI-DI: 04046955135721.

Distribution pattern: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.