Home / Recalls / Sorin Group USA, Inc. / Z-2789-2017

Z-2789-2017 Class II Terminated

Recalled by Sorin Group USA, Inc. — Arvada, CO

Recall Details

Product Type
Devices
Report Date
August 9, 2017
Initiation Date
June 29, 2017
Termination Date
April 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA

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.

Distribution Pattern

Nationwide

Code Information

Lot Number 1703300074

Other recalls by Sorin Group USA, Inc.

  • Z-0076-2018 Class II — FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannul (September 28, 2017)
  • Z-2774-2017 Class II — STOCKERT Heater-Cooler System 3T, 127V/60 Hz (June 30, 2017)
  • Z-2773-2017 Class II — STOCKERT Heater-Cooler System 3T, 208V/60 Hz (June 30, 2017)
  • Z-2772-2017 Class II — STOCKERT Heater-Cooler System 3T, 240V/60 Hz (June 30, 2017)
  • Z-2771-2017 Class II — STOCKERT Heater-Cooler System 3T, 230 V (June 30, 2017)
  • Z-2776-2017 Class II — STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz (June 30, 2017)
  • Z-2775-2017 Class II — STOCKERT Heater-Cooler System 3T, 120V/60 Hz (June 30, 2017)
  • Z-2798-2017 Class II — NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT (June 29, 2017)
  • Z-2794-2017 Class II — SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Onl (June 29, 2017)
  • Z-2786-2017 Class II — SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx On (June 29, 2017)