Class IIReported 2025-12-03

Caresite 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. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206.

Reason for Recall

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

Recall Number

Z-0624-2026

Classification

Class II

Status

Ongoing