Recall Z-2797-2017— Sorin Group USA, Inc.

Name: FDA recall Z-2797-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-29

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2017-06-29, terminated 2021-04-12. It names one FDA 510(k) clearance: K981613. Product: NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE. Reason: 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..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Terminated: 2021-04-12
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K981613 — COBE SMARXT TUBING AND CONNECTORSCobe Cardiovascular, Inc.·cleared 1998-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.