NON-STERILE SAMPLE recalled over sterility concerns

Recall date

June 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sorin Group USA, Inc. recalls NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE

Recall number

Z-2796-2017

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE