SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA

Class I - Dangerous

🏥 Medical Devices Recalled: June 29, 2017 Sorin Group USA Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Lot Numbers: 1626400126, 1628100032, 1631900034, 1632800034, 1703300043, 1707400063, 1708000042, 1710000040, 1716500018
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Sorin Group USA, Inc.
Reason for Recall:: Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA

Product Codes/Lot Numbers:

Lot Numbers: 1626400126, 1628100032, 1631900034, 1632800034, 1703300043, 1707400063, 1708000042, 1710000040, 1716500018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2786-2017

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