Perfusion Pack recallZ-0664-2018 · LivaNova USA · initiated Dec 19, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from LivaNova USA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product is labeled with the incorrect expiration date.
FDA root cause category: Process control
What the company is doing
The recalling firm issued a letter dated 12/7/2017 via email on 12/19/2017.
Recall details
- Recall number
- Z-0664-2018
- Status
- Terminated
- Initiated by the company
- Dec 19, 2017
- Recalling firm
- LivaNova USA
- Quantity
- 16 units (6 from lot 1717800062 and 10 units from lot 1720800071
- Product code
- DWE
- FDA submissions
- K981613
- Distribution
- Distribution was made to one consignee in LA.
Product description
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Code information (models, lots, serial numbers)
Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perfusion PackLivanova USA, Inc.1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K981613 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ConnectorLivanova USA, Inc. · Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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