Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP
FDA device recall Z-2157-2025 · posted 2025-07-22 · Open, Classified
Recall details
- Recalling firm
- Bridge to Life Ltd
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KDN
- Quantity affected
- 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
- Date initiated
- 2025-06-12
- Date posted
- 2025-07-22
- Location
- Northbrook, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EasiSlush (K191006) | Bridge TO Life, Ltd. | 2019-09-24 |