TransMedics OCS Liver Perfusion Set recalled for incorrect accessories
This recall covers 46 TransMedics OCS Liver Perfusion Sets (model 3200), which were incorrectly assembled and contain incorrect accessories. The sets were distributed in 12 states, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All TransMedics recalls
What to do
- Set aside affected accessory lots: 4483-2-742422 (OCS Liver Instrumentation Tool Set, exp. 2027-07-09) and 4484-2-743965 (OCS Liver Perfusion Termination Set, exp. 2027-08-04).
- Contact TransMedics about the affected sets. The notice does not specify a remedy, so ask the manufacturer how to return or replace them.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- OCS Liver Perfusion Set Model/Catalog Number: 3200 OCS Liver Perfusion Sets containing OCS Liver Instrumentation Tool Set and OCS Liver Perfusion Termination Set, components of the Liver Perfusion Set (or available as separately shippable replacement accessories) intended to be used with the OCS console for organ transport.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 46
- Illnesses reported
- None reported
- Manufactured in
- 200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
- Classification
- Class II
- Recall number
- Z-0383-2027
In the FDA's words
- Description
- OCS Liver Perfusion Set Model/Catalog Number: 3200 OCS Liver Perfusion Sets containing OCS Liver Instrumentation Tool Set and OCS Liver Perfusion Termination Set, components of the Liver Perfusion Set (or available as separately shippable replacement accessories) intended to be used with the OCS console for organ transport. Incorrectly assembled device sets with incorrect accessories. 1. Accessory Set Lot: 4483-2-742422; Description: OCS Liver Instrumentation Tool Set; EXP Date: 2027-07-09; UDI: +B00944833/$$74483-2-742422/14D20270709K; 2. Accessory Set Lot: 4484-2-743965; Description: OCS Liver Perfusion Termination Set; EXP Date: 2027-08-04; UDI: +B00944843/$$74484-2-743965/14D20270804V; Distribution: US Nationwide distribution in the states of AZ, CA, CO, FL, GA, MA, MI, MN, NC, NJ, TX, WA. Affected quantity: 46
- Hazard
- Incorrectly assembled device sets with incorrect accessories.
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