Recall Weekly
Moderate riskFDA DeviceClass II

TransMedics OCS Heart tool set recalled for incorrect components

Some TransMedics OCS Heart Instrumentation Tool Sets, accessories used with the OCS console for organ transport, were incorrectly assembled and include incorrect components. The recall covers 29 units across two lots. The FDA lists this as a Class II recall, and no injuries have been reported.

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

What to do

  1. Set aside any affected lots and do not use them until you have contacted TransMedics.
  2. Check for catalog number 1401 with lot 3664-7-722242 or 3636-9-722243 and expiration date 2027-01-31.
  3. The notice doesn't say how to get a replacement or correction; contact TransMedics, Inc. for next steps.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
OCS Heart System OCS Heart Instrumentation Tool Set Model/Catalog Number: 1401 OCS Heart Instrumentation Tool Set, accessories intended to be used with the OCS console for organ transport
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
29
Illnesses reported
None reported
Manufactured in
200 Minuteman Rd Ste 302, Andover, Massachusetts, United States
Classification
Class II
Recall number
Z-0386-2027

In the FDA's words

Description
OCS Heart System OCS Heart Instrumentation Tool Set Model/Catalog Number: 1401 OCS Heart Instrumentation Tool Set, accessories intended to be used with the OCS console for organ transport Incorrectly assembled device kits that include incorrect components. Lot: 3664-7-722242 / 3636-9-722243; Description: OCS Heart Instrumentation Tool Set; EXP Date: 2027-01-31; UDI: +B00936645/$$73664-7-722242/14D20270131E / +B00936363/$$73636-9-722243/14D20270131E; Distribution: Worldwide - US Nationwide distribution in the states of NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA and the countries of Australia, France, Italy, Taiwan. Affected quantity: 29
Hazard
Incorrectly assembled device kits that include incorrect components.

3 products in this recall

TransMedics OCS perfusion sets recalled for incorrect components

TransMedics recalled three OCS products: the OCS Heart Perfusion Set (Model 1200), the OCS Liver Perfusion Set (Model 3200), and the OCS Heart Instrumentation Tool Set (Model 1401). The FDA says the device kits were incorrectly assembled and include incorrect components. The recall was distributed nationwide in the US (NE, AZ, CA, FL, GA, IL, MA, MI, MN, NC, NJ, OH, TX, UT, WA) and in Australia, France, Italy and Taiwan. No injuries have been reported.

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

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