Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
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 an FDA Class II medical device with a labeling error that mislabels non-sterile solution as sterile. No illnesses or injuries are reported in the source text. However, using non-sterile solution in sterile gynecological procedures creates a risk of infection. Per the rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' meriting a score of 3 (High).
Plain-English summary
Medline Industries, LP is recalling its Non-Sterile PVP Solution packaged in Hystero Pack kits (Model DYNJ61448A) with Lot Number 23CBS268 due to labeling errors.
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been labeled "NON-STERILE PVP SOLUTION, STERILE PACKAGING". This labeling error is significant because the product is packaged for gynecological use, where sterility is critical.
When non-sterile solution is used in sterile surgical procedures, there is a risk of introducing pathogens and causing post-operative infections. For gynecological procedures, this could result in surgical site infections or other serious complications.
Customers who have received affected lots should cease use immediately and contact Medline Industries for instructions on product return or replacement with correctly labeled units.
The recalled product
- Product
- MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- labeling-error
- 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 (3)
- UDI/DI (EA) (01)10193489799477
- UDI/DI (01)40193489799478
- Lot Numbers: 23CBS268
Distribution
Distributed nationwide across the United States.
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