FDAClass IMarch 6, 2024

Centurion Kits recall: Sterility Concern

Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010

Why was Centurion Kits recalled?

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF ET1010, UDI/DI 10653160234913 (case), 00653160234916 (unit), Lot Numbers: 2022042290

Product
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
60 units
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Recall date
March 6, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls