Medline Colorectal Convenience Kits Recalled for Potential Sterility Breach
Medline is recalling 176 colorectal convenience kits due to potential packaging defects that may compromise sterility, posing a risk of microbial contamination.
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 FDA Class II, and the source text describes potential for serious infection and hospitalization without reporting specific confirmed injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 176 units of Medline Convenience Kits, specifically the COLORECTAL ME model (Model Number: DYNJ906437D). The recall involves five specific lot numbers: 23LBL348, 24BBA259, 24BBN513, 24BBS350, and 24BBU576. These kits were distributed nationwide in the United States.
The recall is being issued because the kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators that may have a breach of sterility in the packaging. This potential breach is attributed to wrinkles in the paper lidding that may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences of exposure to microbial contamination may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening. Users should check their inventory for the affected model and lot numbers and contact Medline for further instructions.
The recalled product
- Product
- Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437D
- Manufacturer
- Medline Industries, LP
- Affected units
- 176
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 (12)
- 1) DYNJ906437D
- UDI-DI: 10195327542085(each)
- 40195327542086(case)
- Lot Number: 23LBL348
- 2) DYNJ906437D
- Lot Number: 24BBA259
- 3) DYNJ906437D
- Lot Number: 24BBN513
- 4) DYNJ906437D
- Lot Number: 24BBS350
- 5) DYNJ906437D
- Lot Number: 24BBU576
Distribution
Distributed nationwide across the United States.
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