Medline Centurion dialysis kits recalled due to sterility concerns
Medline Industries is recalling approximately 10,391 Centurion dialysis kits due to potential lack of sterility in Nurse Assist components. Products were distributed nationwide and in select international locations.
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 classification requires a minimum Severe rating per regulatory guidelines. The potential lack of sterility in dialysis kit components warrants this severity level, despite no reported illnesses or injuries.
Plain-English summary
Medline Industries, LP is recalling certain Centurion kits and trays manufactured using specific lots of Nurse Assist components. The affected products include Dialysis Accessory Packs (REF MNS10750A), Dialysis ON Kits (REF DT21235A), and Infusa Port Kits (REF DYNDC3166A), totaling 10,391 units.
The recall was issued due to potential lack of sterility in the following Nurse Assist components: 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Non-sterile solutions could result from this manufacturing defect.
The affected kits were distributed nationwide across the United States, including Puerto Rico, as well as in Canada, United Arab Emirates, and Panama.
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
- Category
- Medical Device — Dialysis
- Hazard
- 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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