Medline Eye and Cataract Kits Recalled for Potential Sterility Breach
Medline is recalling 2,080 eye and cataract preop kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
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 source text explicitly states that potential health consequences include hospitalization and that severe infection could become life-threatening, which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury or hospitalization reports.
Plain-English summary
Medline Industries, LP is recalling 2,080 units of Eye Kits and Cataract Preop Kits distributed nationwide in the United States. The affected products include specific model numbers and lot numbers of EYE KIT and CATARACT PREOP KIT convenience kits.
The recall was initiated because the kits contain BD ChloraPrep Clear and FREPP Clear applicators that have a potential breach of sterility in the packaging. Wrinkles in the paper lidding may extend to the seal area, which could compromise the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Consumers should check their inventory for the specific model numbers and lot numbers listed in the recall notice and stop using the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,080
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 (20)
- 1) DYKM2751
- UDI-DI: 10198459118395(each)
- 40198459118396(case)
- Lot Number: 24LBQ727
- 2) DYKM2751
- Lot Number: 24JBB775
- 3) DYKM2751A
- UDI-DI: 10198459313301(each)
- 40198459313302(case)
- Lot Number: 25KMD727
- 4) DYKS1583A
- UDI-DI: 10198459146640(each)
- 40198459146641(case)
- Lot Number: 24KBP388
- 5) DYKS1583A
- Lot Number: 24JBA739
- 6) DYKS1583B
- UDI-DI: 10198459292699(each)
- 40198459292690(case)
- Lot Number: 25DBM037
Distribution
Distributed nationwide across the United States.
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