# FDA recall Z-2157-2025

> **Bridge to Life Ltd** · Class II · device recall initiated 2025-06-12.

## Product

Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP),  Part Number REF BTLE-1250

## Reason for recall

The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024.  Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.

## Distribution

United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada

## Key facts

- **Recall number:** Z-2157-2025
- **Recalling firm:** Bridge to Life Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-12
- **Report date:** 2025-07-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2025

## Citation

> AI Analytics. FDA recall Z-2157-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2157-2025. Source: US FDA. Licensed CC0.

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