Medline Dialysis Kits Recalled for Potential Sterility Defects
Medline Industries is recalling certain dialysis kits and trays due to potential sterility defects in component irrigation solutions and saline products. Non-sterile solutions used in dialysis could cause infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which the rubric mandates never goes below 4 (Severe). No illnesses or injuries have been reported, preventing a Critical classification. The hazard—lack of sterility in medical devices used for invasive dialysis procedures—presents significant patient risk.
Plain-English summary
Medline Industries, LP is recalling certain dialysis kits, trays, and packs labeled as DIALYSIS ON/OFF BNDLE - NO DRSG (Reference DYNDC3088). The recalled products contain component solutions manufactured by Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringes.
The recall was initiated because these component solutions have the potential to lack sterility. Non-sterile irrigation solutions could pose a risk of infection when used in dialysis procedures.
The affected products were distributed nationwide in the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama. The recalled lot numbers are 21LBT672 and 22BBG831, with 35 units affected.
The FDA classified this as a Class I recall, indicating the highest level of regulatory action. No illnesses or injuries related to these products have been reported as of this recall.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-defect
- infection-risk
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 (4)
- UDI/DI 40193489884501 (case)
- 10193489884500 (unit)
- Lot Numbers: 21LBT672
- 22BBG831
Distribution
Distributed nationwide across the United States.
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