Medline Centurion Eye Prep Kit Sterilization Defect Recall
Medline Industries is recalling Centurion Eye Prep Kits due to potential lack of sterility in irrigation solution components manufactured by Nurse Assist.
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: The FDA classification for this recall is Class I, which establishes a minimum severity score of 4 per the severity rubric. No illnesses or injuries have been reported, but the hazard involves potential non-sterility in medical irrigation solutions, posing a contamination risk.
Plain-English summary
Medline Industries, LP is recalling Centurion Eye Prep Kits (REF ET1010) that were manufactured using specific lots of components from Nurse Assist, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. The recall affects 60 units distributed with lot number 2022042290.
Nurse Assist determined that specific lots of these components may lack adequate sterility, which could result in non-sterile irrigation solution being distributed with the kits. Non-sterile irrigation solutions pose a potential contamination risk in medical device applications.
The recalled kits were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, the United Arab Emirates, and Panama.
The recalled product
- Product
- Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- lack-of-sterility
- contamination
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 (4)
- REF ET1010
- UDI/DI 10653160234913 (case)
- 00653160234916 (unit)
- Lot Numbers: 2022042290
Distribution
Distributed nationwide across the United States.
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