Recall Weekly
Moderate riskFDA DeviceClass II

TransMedics OCS Liver Perfusion Set recalled for possible leaks

Some OCS Liver Perfusion Sets contain solution delivery cassettes with syringes made with an atypical lubricant. This may cause sub-par performance and has the potential to cause leaks. The affected sets have serial numbers 4470-3-18076 to 4470-3-20343 and may contain cassettes from lots 4459-6-737116 to 4459-6-739965.

From the FDA notice · Read the official notice ↗ · All TransMedics recalls

What to do

  1. Check whether each Liver Perfusion Set's serial number falls between 4470-3-18076 and 4470-3-20343.
  2. For affected sets, check whether their SDS cassettes come from lots 4459-6-737116 to 4459-6-739965. Each set contains three cassettes.
  3. Set aside affected sets and contact TransMedics, Inc. for guidance. The notice does not specify a remedy.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
OCS Liver System for organ transport OCS Liver Perfusion Set Model/Catalog Number: 3200 Product Description: The recalled product is a standard off the shelf syringe. It is used as part of solution delivery cassette (SDS Cassette) to be used with the perfusion module of OCS Liver System. OCS Liver Perfusion Sets within the serial number range between 4470-3-18076 and 4470-3-20343 may contain SDS cassettes within the impacted lot range of 4459-6-737116 to 4459-6-739965. Each Liver Perfusion Set contains three SDS cassettes. The BD syringe is a component of SDS Cassette PN 100004459, which is an accessory of the Liver Perfusion Set.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
1179 (Liver Perfusion Sets)
Illnesses reported
None reported
Manufactured in
200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification
Class II
Recall number
Z-0389-2027

In the FDA's words

Description
OCS Liver System for organ transport OCS Liver Perfusion Set Model/Catalog Number: 3200 Product Description: The recalled product is a standard off the shelf syringe. It is used as part of solution delivery cassette (SDS Cassette) to be used with the perfusion module of OCS Liver System. OCS Liver Perfusion Sets within the serial number range between 4470-3-18076 and 4470-3-20343 may contain SDS cassettes within the impacted lot range of 4459-6-737116 to 4459-6-739965. Each Liver Perfusion Set contains three SDS cassettes. The BD syringe is a component of SDS Cassette PN 100004459, which is an accessory of the Liver Perfusion Set. Faulty Solution Delivery System (SDS) Cassettes within the device set were assembled with syringes that were manufactured with an atypical lubricant, which results in sub-par performance and has the potential to cause leaks. OCS Liver Perfusion Set Serial Numbers from 4470-3-18076 to 4470-3-20343; Distribution: Worldwide - US Nationwide distribution in the state of NE and the country of Italy. Affected quantity: 1179 (Liver Perfusion Sets)
Hazard
Faulty Solution Delivery System (SDS) Cassettes within the device set were assembled with syringes that were manufactured with an atypical lubricant, which results in sub-par performance and has the potential to cause leaks.

3 products in this recall

TransMedics OCS Liver System sets recalled for potential leaks

TransMedics is recalling three OCS Liver System products: Liver Perfusion Sets (model 3200), Liver Solution Infusion Sets (model 3457), and Solution Delivery Cassettes (model 1467). The cassettes were assembled with syringes made with an atypical lubricant, which may cause sub-par performance and has the potential to cause leaks. The recall covers 1,179 perfusion sets, 90 infusion sets and 55 cassettes, distributed nationwide in Nebraska and to Italy, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

More from TransMedics

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device