# FDA recall Z-1050-2026

> **Medline Industries, LP** · Class II · device recall initiated 2025-11-26.

## Product

Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:    1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O;   2) OPEN HEART CDSKit SKU CDS984355K;   3) BAG A OPEN HEART KITKit SKU DYKM1025D;   4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752O;   5) OPEN HEART CDSKit SKU DYNJ902879T;   6) BASIC CARDIAC ANESTHESIAKit SKU DYNJ903523F;   7) OPEN HEART CDSKit SKU DYNJ905557B;   8) AN03 HEART/ANESTHESIA KIT-LFKit SKU PHS972012D.

## Reason for recall

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1050-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2026-01-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2026

## Citation

> AI Analytics. FDA recall Z-1050-2026. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1050-2026. Source: US FDA. Licensed CC0.

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