Official recall record
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-06-12
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10860001991205
- Brand on record
- Bridge to Life Ltd
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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