EasiSlush sterile slush solution missed a quarterly gamma sterilization dose audit
Bridge to Life EasiSlush is being recalled because quarterly dose audits monitoring the gamma sterilization process were not completed on time for three lots in the first quarter of 2024. 4,528 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall over a missed process-monitoring audit where routine lot testing was completed properly and no sterility failure is stated.
Plain-English summary
Bridge to Life EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation, 0.9% Sodium Chloride Irrigation, USP), part number REF BTLE-1250, is being recalled. The action covers 4,528 units.
According to the firm, a field safety notice was issued after it became aware of three lots of product not having quarterly dose audits completed on time in the first quarter of 2024. The notice states that routine lot by lot testing was completed properly, and that the quarterly dose audit is a sampling and testing step used to monitor the gamma sterilization process. The FDA classified the action as Class II. The source does not report any sterility failure having been found.
Distribution was in New York, Maryland, Alabama, North Carolina, South Carolina and Ohio among other states. The product is supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the REF and UDI codes above and follow the instructions issued by the manufacturer.
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
- Affected units
- 4,528
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
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