Reported Jul 30, 2025 · Ongoing
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation,…
Bridge to Life Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bridge to Life Ltd · 707 Skokie Blvd Ste 340 · Northbrook, IL · 60062-2838
Is this the product you have?
- Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 1086000199120500860001991208UDI 10860001991205-240206-260206-240372708 (case), 00860001991208-240206-260206-240372708 (bag), Lot Number 240372708 2 1086000199120500860001991208UDI 10860001991205-240212-260212-240402836 (case), 00860001991208-240212-260212-240402836 (bag), Lot Number 240402836 3 1086000199120500860001991208UDI 10860001991205-240214-260214-240402837 (case), 00860001991208-240214-260214-240402837 (bag), Lot Number 240402837. - Amount recalled
- 4528 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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