Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
FDA enforcement status: Ongoing
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-0012026-05-08
- FDAVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-0002026-03-25
- FDATirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.2026-02-26
- FDASemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.2026-02-26
- FDASemaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-062026-02-26
- FDATirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.2026-02-26
- FDAArtelon FlexBand Dynamic Matrix Ref: 310572026-02-06
- FDAArtelon FlexBand Plus Ref: 41054 & 410572026-02-06
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