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.
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: 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
- Affected units
- 10,391
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
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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