FDAFDA · Food and drugs·Recall number Z-2798-2017
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Published August 9, 2017 · Recall initiated: June 29, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Sorin Group USA, Inc.
- Distributor
- Nationwide
- Lot
- Lot Number 1703700067
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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