# FDA recall Z-0670-2026

> **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 DR W/2 SAFEDAY; Catalog Number: 352636.     2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639.     3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640.     4.	IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643.     5.	IV ADMIN SET, 105 IN.; Catalog Number: 477003.     6.	IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006.     7.	IV ADMIN SET, 121 IN.; Catalog Number: 477008.     8.	IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012.     9.	IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019.     10.	IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021.     11.	IV ADMIN SET 114 IN.; Catalog Number: 477022.     12.	IV ADMIN SET 5 CARESITE LA

## 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-0670-2026
- **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-0670-2026

## Citation

> AI Analytics. FDA recall Z-0670-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0670-2026. Source: US FDA. Licensed CC0.

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