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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 35
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
Part of a larger recall action
This product is one of 49 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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