Medline Triple Lumen Insertion Kits Recalled for Sterilization Calibration
Medline Industries is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) due to calibration issues with sterilization equipment that may have compromised the sterility assurance level of the products.
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 FDA classified this as a Class II medical device recall. The hazard involves potential loss of sterility assurance on a device inserted into the body; no illnesses or injuries have been reported, but the risk of contamination and serious harm is inherent to compromised sterility on invasive medical devices.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits—specifically the Triple Lumen Insertion Kit (Model Number DYNDM1031A, Lot Number 23EBM150)—distributed nationwide and worldwide. The recall affects 15 units.
Medline identified calibration issues with the equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration defects have the potential to impact the sterility assurance level (SAL) of the recalled products, meaning the devices may not maintain the expected level of sterility.
Consumers and healthcare facilities in possession of this product should discontinue use and contact Medline Industries for instructions on return or replacement of the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
- Manufacturer
- Medline Industries, LP
- Hazard
- sterility-assurance
- sterilization-failure
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 (4)
- 1) DYNDM1031A
- UDI-DI: 10884389555897(each)
- 40884389555898(case)
- Lot Number: 23EBM150
Distribution
Distributed nationwide across the United States.