CARESAFE 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 numbers: 1. CARESAFE IV ADMIN SET w/AIRSTOP, 104 IN.; Catalog Number: 354302. 2. CARESAFE ADMIN SET w/15um FILTER, 104 IN; Catalog Number: 354303. 3. CARESAFE IV ADMIN SET w/AIRSTOP, 114 IN.; Catalog Number: 354304. 4. CARESAFE ADMIN SET w/15um FILTER, 114 IN; Catalog Number: 354305. 5. CARESAFE IV ADMIN SET w/AIRSTOP, 110 IN.; Catalog Number: 354306. 6. CARESAFE ADMIN SET w/15um FILTER, 110 IN; Catalog Number: 354307. 7. CARESAFE" IV Administration Set with AirStop Filter, Not made with PVC or DEHP, 2 CARESITE¿ Injection Sites, 2 ULTRAPORT¿ High-FlowFour-Way Stopcocks; CARESAFE ANESTH SET W/AIRSTOP, 134 IN.; Catalog Number: 354308. 8. CARESAFE ANESTH SET w/15um FILTER,134IN.; Catalog Number: 354310.

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: 354302; Primary UDI-DI: 04046955259946; Unit of Dose UDI-DI: 04046955259939. 2. Catalog Number: 354303; Primary UDI-DI: 04046955052424; Unit of Dose UDI-DI: 04046955052417. 3. Catalog Number: 354304; Primary UDI-DI: 04046955259960; Unit of Dose UDI-DI: 04046955259953. 4. Catalog Number: 354305; Primary UDI-DI: 04046955052448; Unit of Dose UDI-DI: 04046955052431. 5. Catalog Number: 354306; Primary UDI-DI: 04046955259984; Unit of Dose UDI-DI: 04046955259977. 6. Catalog Number: 354307; Primary UDI-DI: 04046955052462; Unit of Dose UDI-DI: 04046955052455. 7. Catalog Number: 354308; Primary UDI-DI: 04046955260003; Unit of Dose UDI-DI: 04046955259991. 8. Catalog Number: 354310; Primary UDI-DI: 04046955052929; Unit of Dose UDI-DI: 04046955052905.

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