Medline Non-Sterile PVP Solution Kits Mislabeled as Sterile
Medline is recalling Total Knee Theda surgical kits where the non-sterile PVP solution was mislabeled as sterile. Healthcare providers should immediately stop using the recalled kits and contact Medline.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall involves a risk-of-harm product where non-sterile solution is mislabeled as sterile, which could result in use in sterile medical contexts. No illnesses or injuries have been reported. The FDA Class II classification supports this severity level.
Plain-English summary
Medline Industries is recalling Total Knee Theda kits (Model Number DYNJ908683A) containing non-sterile PVP solution. Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been labeled "NON-STERILE PVP SOLUTION, STERILE PACKAGING." This mislabeling creates a risk that healthcare providers might use non-sterile solution in applications where sterile product is required.
The recall affects 144 units distributed nationwide in the United States and Panama. Lot number 23DDA761 is involved.
Healthcare providers and facilities should immediately stop using the recalled kits and contact Medline Industries for return instructions and replacement products. Facilities that may have used these kits should review their records to identify any potential exposures.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 144
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 (EA) 10159327251772
- UDI/DI (CS) 40195327251773
- Lot Numbers: 23DDA761
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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