Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP
Summary
The FDA issued a Class II for Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparatio by Bridge to Life Ltd. Reason: 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 f.
Details
Source
Device Recall
External ID
Z-2157-2025
Action Date
2025-07-30
Status
Ongoing
Category
device
Product Description
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Lot/Code Info: UDI 10860001991205-240206-260206-240372708 (case), 00860001991208-240206-260206-240372708 (bag), Lot Number 240372708; UDI 10860001991205-240212-260212-240402836 (case), 00860001991208-240212-260212-240402836 (bag), Lot Number 240402836; UDI 10860001991205-240214-260214-240402837 (case), 00860001991208-240214-260214-240402837 (bag), Lot Number 240402837.
Quantity Affected: 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-12
Company
Northbrook, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 122 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bridge to Life Ltd has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bridge to Life Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bridge to Life Ltd have FDA actions?
Bridge to Life Ltd has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2157-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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