MTS Set dialysis accessory recalled for freezing temperature exposure during transport
Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.
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: This Class II medical device recall involves a risk-of-harm product where the hazard is sterility compromise of a single-use sterile device used in peritoneal dialysis treatment. No illnesses or injuries have been reported; the hazard is theoretical but potentially serious given the device's direct connection to the patient's peritoneal cavity.
Plain-English summary
Fresenius Medical Care Holdings, Inc., is recalling the MTS Set, a single-use sterile medical accessory used with peritoneal dialysis cycler sets during acute and chronic dialysis treatment. The MTS Set provides additional connection points and utilizes PIN engagement technology compatible with Fresenius stay-safe patient connectors.
The recall is due to exposure of affected lots to freezing temperatures caused by refrigerated truck malfunctions during distribution. This temperature exposure may compromise the sterility assurance of the device, which is critical for its safe use in dialysis treatment where direct connection to the patient's peritoneal cavity is required.
The recall affects 5 cases distributed to Texas. Patients, care partners, and healthcare professionals using MTS Sets from the recalled lot numbers (20SR08069 and 20PR08237) should discontinue use and contact Fresenius or their healthcare provider for replacement or guidance. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used in
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 5
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 9 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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