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.
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 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
- lack-of-sterility
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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