Medline Non-Sterile PVP Solution Mislabeled as Sterile in Ophthalmic Kits
Medline Industries is recalling 1,500 units of non-sterile PVP solution mislabeled as sterile in ophthalmic and eye surgical kits. Users may unknowingly apply non-sterile solution in eye procedures, risking infection.
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: The recall is classified as High under the risk-of-harm criterion: non-sterile solution mislabeled as sterile in ophthalmic surgical kits creates a direct infection risk if used, though no illnesses have been reported. The FDA Class II classification aligns with this severity level.
Plain-English summary
Medline Industries, LP is recalling 1,500 units of non-sterile PVP solution that was mislabeled as sterile. The affected products are packaged in two surgical kit models: OCULOPLASTY PACK (Model DYNJ64572A) and EYE PACK (Model VAL050EEPKB).
The products are mislabeled as 'STERILE PVP SLN' when they should have been labeled 'NON-STERILE PVP SOLUTION, STERILE PACKAGING.' This mislabeling creates a significant risk because healthcare providers may unknowingly use non-sterile solution in ophthalmic and eye surgical procedures, where sterility is critical.
The affected products have been distributed nationwide in the United States and to Panama. Specific lot numbers are documented for tracking: Model DYNJ64572A includes lots 23FBA458 and 23DBC239; Model VAL050EEPKB includes lots 23EBA381, 23CBI693, and 23BBE528.
Healthcare facilities and providers who received these kits should immediately identify and quarantine the affected lots. The products should not be used in any ophthalmic procedures.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-mislabel
- infection-risk
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 (11)
- a) Model Number DYNJ64572A
- UDI/DI (EA) 10195327112554
- (CS) 40195327112555
- Lot Numbers:23FBA458
- 23DBC239
- b) Model Number VAL050EEPKB
- UDI/DI (EA) 10195327267149
- (CS) 40195327267149
- Lot Numbers: 23EBA381
- 23CBI693
- 23BBE528
Distribution
Distributed nationwide across the United States.
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