Home / Recalls / Terumo Cardiovascular Systems Corporation / Z-0966-2019

Z-0966-2019 Class II Terminated

Recalled by Terumo Cardiovascular Systems Corporation — Elkton, MD

Recall Details

Product Type
Devices
Report Date
March 6, 2019
Initiation Date
December 20, 2018
Termination Date
August 20, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 packs

Product Description

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222

Reason for Recall

Presence of natural rubber latex is not declared in the label

Distribution Pattern

TX

Code Information

Lot Numbers: V A30

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  • Z-1401-2024 Class II — Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Pa (February 20, 2024)
  • Z-1347-2023 Class II — CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC (March 1, 2023)
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  • Z-2350-2021 Class II — Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 8 (June 8, 2021)
  • Z-1789-2021 Class II — The Terumo HX2 Temperature Management System provides temperature control of two (April 16, 2021)
  • Z-1790-2021 Class II — The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature- (April 16, 2021)
  • Z-1791-2021 Class II — The Sarns TCM II (system) is a source of temperature-controlled water for blood (April 16, 2021)