B Braun Medical Inc: Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Out
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- B Braun Medical Inc
- Product
- 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 15 DROP W/2 CARESITE; Catalog Number: 354202. 2. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADM 15DROP W/2 CARESITE SLIDECLMP; Catalog Number: 354203.
- Reason / hazard
- Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
- Recall initiated
- 2025-10-29
- Code info
- 1. Catalog Number: 354202; Primary UDI-DI: 04046964182037; Unit of Dose UDI-DI: 04046964182020. 2. Catalog Number: 354203; Primary UDI-DI: 04046964182051; Unit of Dose UDI-DI: 04046964182044.
- Product quantity
- 2,871,707 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bethlehem
- State
- PA
- Country
- United States
- Event id
- 97816
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