Medline Convenience Kits recalled for fungal contamination in sterile applicators
What this means
Medline Convenience Kits contain sterile applicators that may be contaminated with Aspergillus penicillioides fungus. This contamination could occur during manufacturing under certain environmental conditions. If these kits are used on skin, the fungal contamination could potentially lead to serious infections.
- Check if you have Medline Convenience Kits with catalog numbers DYKM1414 (Lot 24HBS933) or DYNJ38145F (Lot 24HBT600).
- Do not use affected kits.
- Contact Medline Industries or your healthcare facility for instructions on return or disposal.
- If you or a patient has been treated with an affected kit and develops signs of infection (fever, redness, swelling, or drainage), contact a healthcare provider immediately.
The agency's original wording
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3123-2026More Medline recalls
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