EasiSlush Solution (Bridge to Life) – Audit Timing Issue (2025)
Quarterly dose audit delays may potentially compromise product sterility monitoring processes.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Brand
Bridge to Life Ltd
Lot Codes / Batch Numbers
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.
Products Sold
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.
Bridge to Life Ltd is recalling Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chlo due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Bridge to Life issued an IMPORTANT FIELD SAFETY NOTICE to its consignees on 06/12/2025 via email. The notice explained the issue and requested the following: Actions required by the customer: 1. To be aware and acknowledge this field safety notice. 2. We are requesting customers to conduct a review of the existing EasiSlush inventory to determine if you have any quantities of the following three lot numbers 240372708, 240372836, 240402837. 3. If you may have further distributed the product, we request that quantity be included in your review and please advise us on where your product is forwarded with contact information. 4. Immediately notify Bridge to Life of the quantities in inventory. Fill out FSN Customer Reply Form below and send it back to the email address Vigilance@B2LL.com 5. FSN Customer Reply Form must be returned no later than June 18, 2025. 6. Lastly, please confirm no adverse events related to the subject lots and advise if you have any additional questions or concerns. For questions, please contact Vigilance@B2LL.com or 800-667-9524.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026