Medline PVP solution mislabeled as sterile when non-sterile
Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.
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 is an FDA Class II recall involving mislabeling of a medical device. The hazard is risk of using a non-sterile product in sterile medical contexts, which could cause infection or contamination. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 183,240 units of NON-STERILE PVP SOLUTION, STERILE PACKAGING (Ref DYNDA2232A) from eight batches manufactured in 2023. The affected products are identified by batch numbers 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, and 2023022490 (GTIN 10889942851850).
The affected products are labeled incorrectly as "STERILE PVP SLN" when they should be labeled "NON-STERILE PVP SOLUTION, STERILE PACKAGING." This mislabeling creates a risk that healthcare providers or users may inadvertently use a non-sterile product in medical or surgical settings where sterile product is required, potentially leading to contamination or infection.
The products were distributed worldwide, including throughout the United States and Panama. Healthcare facilities and individuals who received affected batches should verify their inventory against the batch numbers listed above. If affected batches are identified, users should discontinue use and return the product to Medline Industries, LP.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Affected units
- 183,240
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 (9)
- GTIN 10889942851850
- Batch Numbers: 2023011090
- 2023011190
- 2023011790
- 2023012090
- 2023012590
- 2023020790
- 2023022390
- 2023022490
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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