Recall Weekly
Moderate riskFDA DeviceClass II

TransMedics OCS liver system cassettes recalled for potential leaks

Some OCS Solution Delivery Cassettes were assembled with syringes made with an atypical lubricant. This results in 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 cassettes and contact TransMedics and your care team before using them.
  2. Check lot numbers 4460-4-737189, 4460-4-738008, 4460-4-738009 and 4460-4-739728 on OCS Solution Delivery Cassettes, catalog 1467.
  3. The notice doesn't say how to get a replacement or return; ask TransMedics, Inc. directly.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
OCS Liver System for organ transport OCS Solution Delivery Cassettes Model/Catalog Number: 1467 Product Description: OCS Solution Delivery Cassettes 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 Solution Delivery Cassettes contains three SDS cassettes. The BD syringe is a component of the SDS Cassette PN 100004459
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
55 OCS Solution Delivery Cassettes
Illnesses reported
None reported
Manufactured in
200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification
Class II
Recall number
Z-0391-2027

In the FDA's words

Description
OCS Liver System for organ transport OCS Solution Delivery Cassettes Model/Catalog Number: 1467 Product Description: OCS Solution Delivery Cassettes 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 Solution Delivery Cassettes 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 Code: Lot: 4460-4-737189; Expiration Date: 2028-10-08; UDI: +B00944605/$$74460-4-737189/14D20281008/Q3L; Lot: 4460-4-738008; Expiration Date: 2028-11-07; UDI: +B00944605/$$74460-4-738008/14D20281107/Q3C; Lot: 4460-4-738009; Expiration Date: 2028-11-07; UDI: +B00944605/$$74460-4-738009/14D20281107/Q3D; Lot: 4460-4-739728; Expiration Date: 2029-01-14; UDI: +B00944605/$$74460-4-739728/14D20290114/Q3K; Distribution: Worldwide - US Nationwide distribution in the state of NE and the country of Italy. Affected quantity: 55 OCS Solution Delivery Cassettes
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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