Medline Industries recalled 88 units of the Sterile Extremity Pack DYNJ45701B after finding that kits labeled as sterile had not undergone sterilization. The affected distribution covered Florida, Maryland, New Jersey and Tennessee. Hospitals and clinics should stop using the kit immediately and follow Medline's recall instructions.
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 Extremity Pack kits are used in healthcare settings to organize sterile items for procedures. They are intended for use in hospitals or clinics.
If a kit is labeled sterile but not sterilized, contents may be contaminated and pose an infection risk to patients.
This recall is not part of a broader industry pattern.
Hospitals and clinics may need to halt use of affected kits, potentially delaying procedures and increasing waste.
Recall details available at the FDA enforcement page for Z-2593-2025. Official Medline recall communications will be issued to healthcare providers.
Recall processing times vary; replacements or refunds will be communicated by Medline and may take several weeks.
Keep copies of all recall notices, packaging, labels, model/UDI numbers, and correspondence with Medline.
Model numbers: 1) DYNJ45701B. UDI-DI: 10193489856279(each). Case UDI: 40193489856270. Lot Number: 25GBF686. Quantity: 88 units. Distribution: US to FL, MD, NJ, TN. Sold to healthcare facilities in the United States. Price: Unknown.
No injuries or incidents have been reported.
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