Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging
Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a potential sterility breach. Although FDA Class II, no hospitalizations, injuries, or illnesses have been reported. The hazard is theoretical and precautionary, placing it in the High category for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries is recalling 160 units of the Medline EYE PACK (Reference LYN036EPESB), a medical procedure convenience kit, distributed worldwide including the United States, Canada, and Panama.
The recall was initiated after it was determined that certain convenience kits packaged with a breather pouch from lot 323080002 may allow non-sterile conditions. Specifically, if the vendor seal on the pouch is opened or unsealed, the product may no longer remain sterile, creating a potential risk if used in medical procedures.
Consumers and healthcare facilities with this product should not use it. Those who have received the recalled kits should contact Medline Industries for replacement or disposal instructions.
The recalled product
- Product
- Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Eye Care Kit
- Hazard
- non-sterile
- seal-failure
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 (3)
- UDI/DI 40889942863304 (each)
- 10889942863303 (case)
- Lot Numbers: 24ABA894
Distribution
Distributed nationwide across the United States.
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