Bridge to Life Ltd: Device Recall

Recall #Z-2157-2025 · 06/12/2025

Class II: Risk

Recall Details

Recall Number: Z-2157-2025
Classification: Class II
Product Type: Device
Recalling Firm: Bridge to Life Ltd
Status: Ongoing
Date Initiated: 06/12/2025
Location: Northbrook, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4528 units

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.

Product Description

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

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.