Medline Industries, LP recalled 22 sterile convenience kits distributed to Florida, Maryland, New Jersey and Tennessee after determining the kits labeled as sterile had not undergone sterilization. The sterility lapse creates an infection risk for patients. Healthcare facilities and patients should stop using the kits and follow the recall instructions from Medline and the FDA.
Convenience kits labeled as sterile have not gone through the sterilization process.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: E-Mail
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Sterile convenience kits are used to support sterile procedures in clinical settings. These kits are designed to be used in specific medical tasks and are expected to arrive sterile.
If labeling is incorrect and the contents are not sterile, patients can be exposed to infection risk during procedures.
This recall is not identified as part of a broader industry pattern.
Hospitals and clinics must review inventory immediately. The recall could affect sterile procedures and require substitutions or delays.
Model numbers and UDIs are printed on the kit label and packaging. FDA recall page provides official guidance.
Refunds or replacements are typically processed within 4-6 weeks after confirmation of eligibility.
Keep the recall notice, take photos of model numbers and lot numbers, save all communications with Medline or distributors.
Model numbers: DYNJ0382730O; DYNJ61038B. Sold to US healthcare facilities in FL, MD, NJ, TN. Sold since: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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