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Moderate riskFDA DeviceClass II

TransMedics OCS Liver infusion sets recalled for potential leaks

Some syringes used in the solution delivery cassettes of TransMedics OCS Liver Solution Infusion Sets were made with an atypical lubricant. The FDA says this can lead to sub-par performance and has the potential to cause leaks. No injuries have been reported.

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

What to do

  1. Set aside affected Infusion Sets (model 3457) from lots 4889-2-737669, 4889-2-737672, 4889-2-738695, 4889-2-739735, 4889-2-739738 and 4889-2-740521.
  2. Check the lot, expiration date (2028-12-12 to 2029-01-14) and UDI on each set's packaging to confirm whether it is affected.
  3. Contact TransMedics, Inc. about the recall. The notice does not state a remedy or replacement.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
OCS Liver System for organ transport OCS Liver Solution Infusion Set Model/Catalog Number: 3457 Product Description: OCS Liver Solution Infusion Set; 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. Each OCS Liver Solution Infusion Set contains three SDS Cassettes. The BD syringe is a component of the SDS Cassette PN 100004459
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
90 Liver Solution Infusion Sets
Illnesses reported
None reported
Manufactured in
200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification
Class II
Recall number
Z-0390-2027

In the FDA's words

Description
OCS Liver System for organ transport OCS Liver Solution Infusion Set Model/Catalog Number: 3457 Product Description: OCS Liver Solution Infusion Set; 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. Each OCS Liver Solution Infusion Set contains three SDS Cassettes. The BD syringe is a component of the SDS Cassette PN 100004459 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. Lot: 4889-2-737669; Expiration Date 2028-12-18; UDI: +B00948895/$$74889-2-737669/14D20281218D; Lot: 4889-2-737672; Expiration Date: 2028-12-18; UDI: +B00948895/$$74889-2-737672/14D202812187; Lot: 4889-2-738695; Expiration Date: 2028-12-12; UDI: +B00948895/$$74889-2-738695/14D202812127; Lot: 4889-2-739735; Expiration Date: 2029-01-14; UDI: +B00948895/$$74889-2-739735/14D202901144; Lot: 4889-2-739738; Expiration Date: 2029-01-07; UDI: +B00948895/$$74889-2-739738/14D202901079; Lot: 4889-2-740521; Expiration Date: 2029-01-14; UDI: +B00948895/$$74889-2-740521/14D20290114W; Distribution: Worldwide - US Nationwide distribution in the state of NE and the country of Italy. Affected quantity: 90 Liver Solution Infusion 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.

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