Z-2157-2025Class II

Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride...

Name: Z-2157-2025 Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride...
Creator: Bridge to Life Ltd
Published: 2025-06-12
License: https://open.fda.gov/license/

Bridge to Life Ltd / initiated 2025-06-12 / Open, Classified / root cause: manufacturing process

FDA source

Bridge to Life Ltd began a recall of Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250 on 2025-06-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2157-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-12
Posted: 2025-07-22
Recalling firm: Bridge to Life Ltd
Product: Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Product code: KDN System, Perfusion, Kidney
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] 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 [email protected] or 800-667-9524.
Quantity in commerce: 4528 units
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2157-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2157-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-30	2025-07-22

Product code KDN

K191006Class IIEasiSlushBridge TO Life, Ltd. / cleared 2019-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)