Dialysis Irrigation Solutions Recalled for Potential Sterility Defect
Medline Industries is recalling 10,391 units of dialysis kits and accessory packs due to potential sterility defects in component solutions. Non-sterile irrigation fluids could cause serious infection if used.
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: FDA Class I medical device recall for sterility defect in dialysis irrigation solutions. Although no illnesses or injuries have been reported in the source text, the Class I classification and serious infection risk from non-sterile dialysis solutions meet the threshold for Severe severity.
Plain-English summary
Medline Industries, LP is recalling certain dialysis kits, trays, and accessory packs labeled as DIALYSIS ACCESSORY PACK W/O CATHETER (REF MNS10750A), DIALYSIS ON KIT (REF DT21235A), and INFUSA PORT KIT (REF DYNDC3166A). These products contained component solutions manufactured by Nurse Assist: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Approximately 10,391 units are affected.
The recall was initiated because Nurse Assist identified a potential lack of sterility in the component solutions, which could result in the products being non-sterile. Use of non-sterile irrigation solutions in dialysis procedures could introduce contamination and result in serious infection.
The affected products were distributed nationwide throughout the United States, including Puerto Rico, as well as to Canada, the United Arab Emirates, and Panama.
Consumers and healthcare facilities that have received affected units should stop using these products immediately and contact Medline Industries with questions regarding the recall.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A
- 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 (17)
- a) REF MNS10750A
- UDI/DI 00653160348286 (case)
- 10653160348283 (unit)
- Lot Numbers: 2022032150
- 2022053150
- 2022061750
- 2022073050
- b) REF DT21235A
- UDI/DI 00653160348453 (case)
- 10653160348450 (unit)
- Lot Numbers: 2022012701
- c) REF DYNDC3166A
- UDI/DI 00653160350111 (case)
- 10653160350118 (unit)
- Lot Numbers: 2022021150
- 2022031450
- 2022031850
Distribution
Distributed nationwide across the United States.
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