# FDA recall Z-0669-2026

> **B Braun Medical Inc** · Class II · device recall initiated 2025-10-29.

## Product

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 15 DROP W/ CARESITE EXT SET; Catalog Number: 490528.     2. 111 IN. IV ADMIN SET W/ 12 IN. Y-EXT SET; Catalog Number: 490550.     3. IV ADMIN SET, 125 IN. w/ EXT SET 9 IN.; Catalog Number: 490605.     4. IV SET 15 DR 3CARESITE 2 ULTRAPORT; Catalog Number: 490616.     5. IV ADMIN SET, 2 CARSITE LADS; Catalog Number: 490654.

## 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.

## Key facts

- **Recall number:** Z-0669-2026
- **Recalling firm:** B Braun Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-29
- **Report date:** 2025-12-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bethlehem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2026

## Citation

> AI Analytics. FDA recall Z-0669-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0669-2026. Source: US FDA. Licensed CC0.

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