Sodium Chloride Irrigation Solution Missing Sterilization Process Monitoring Audit
Bridge to Life EasiSlush (0.9% sodium chloride irrigation) has been recalled because three lots did not complete required quarterly sterilization process monitoring audits on time during Q1 2024. Routine lot testing was completed properly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported illnesses or adverse events. While routine sterilization and lot testing were completed properly, the quarterly sterilization process monitoring audit required to verify continued effectiveness was not completed on time, prompting this precautionary recall.
Plain-English summary
Bridge to Life EasiSlush (0.9% Sodium Chloride Irrigation, USP) is a sterile irrigation solution used in healthcare settings. The recall affects 4,528 units from three lots that failed to complete required quarterly sterilization process monitoring audits on time during the first quarter of 2024.
The quarterly dose audit is a required test that monitors the gamma sterilization process to verify that validated parameters remain effective and that sterility and bioburden reduction requirements are met. Although routine lot-by-lot testing was completed properly, the quarterly monitoring audit—which confirms the sterilization process is functioning correctly—was not completed on time as required.
The affected product was distributed to facilities in New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and Canada. Healthcare providers should contact Bridge to Life Ltd for instructions regarding replacement or return of the affected lots (240372708, 240402836, 240402837).
The recalled product
- Product
- Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
- Manufacturer
- Bridge to Life Ltd
- Hazard
- sterilization-monitoring-incomplete
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
Distribution scope not specified by the agency.
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