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U.S. Department of Health and Human Services

Class 2 Device Recall Bridge to Life EasiSlush

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 Class 2 Device Recall Bridge to Life EasiSlushsee related information
Date Initiated by FirmJune 12, 2025
Date PostedJuly 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2157-2025
Recall Event ID 97143
510(K)NumberK191006 
Product Classification System, perfusion, kidney - Product Code KDN
ProductBridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Code Information 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.
FEI Number 3015942785
Recalling Firm/
Manufacturer		 Bridge to Life Ltd
707 Skokie Blvd Ste 340
Northbrook IL 60062-2838
For Additional Information ContactMark Harper
847803-545-0080
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionBridge 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.
Quantity in Commerce4528 units
DistributionUnited States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KDN
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