Sterile Prep Stick Recall: Non-Sterile Contents Despite Sterile Labeling
Medline Industries is recalling sterile prep sticks (REF DYNDA1134) labeled as sterile that contain non-sterile solution, posing infection risk in medical procedures.
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 (non-sterile solution labeled as sterile) where no illnesses or injuries have been reported. The FDA Class II classification without reported hospitalization meets the rubric criterion for High (Score 3) severity.
Plain-English summary
Medline Industries, LP is recalling the Sterile Prep Stick (REF DYNDA1134) due to a critical labeling-product mismatch. The product labeling indicates the contents are sterile or identifies the product with the "STRL" designation, however the solution inside the foil sachet is actually non-sterile.
The affected product is distributed nationwide across Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida. The recalled lot is 2023082190, with UDI/DI 40888277098023 (case level) and 10888277098022 (individual unit level).
A non-sterile prep stick labeled and expected to be sterile could result in contamination during use in sterile medical procedures, creating a risk of infection. Consumers and healthcare facilities should stop using the recalled product immediately and contact Medline Industries or their healthcare provider for guidance on proper handling or replacement.
The recalled product
- Product
- STERILE STERILE PREP STICK, REF DYNDA1134
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
- infection-risk
- labeling-mismatch
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 40888277098023 (case)
- 10888277098022 (each)
- Lot numbers: 2023082190
Distribution
Distributed nationwide across the United States.
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