Home / Recalls / Terumo Cardiovascular Systems Corp / Z-0159-2015

Z-0159-2015 Class II Terminated

Recalled by Terumo Cardiovascular Systems Corp — Ashland, MA

Recall Details

Product Type
Devices
Report Date
November 12, 2014
Initiation Date
March 1, 2011
Termination Date
November 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 units

Product Description

Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it.

Reason for Recall

Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line.

Distribution Pattern

Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

Code Information

Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.

Other recalls by Terumo Cardiovascular Systems Corp

  • Z-0949-2022 Class II — Cardiovascular Procedure Kit catalog # 76645 & 73806 (February 3, 2022)
  • Z-1314-2018 Class II — Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte (December 18, 2017)
  • Z-2550-2018 Class II — Tubing Pack Convenience Kit, Product Code 65217 Product Usage: Intended for (May 12, 2017)
  • Z-2706-2016 Class II — Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled contai (July 25, 2016)
  • Z-2791-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: (August 24, 2015)
  • Z-2789-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039 (August 24, 2015)
  • Z-2786-2015 Class II — Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Car (August 24, 2015)
  • Z-2788-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE (August 24, 2015)
  • Z-2792-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: (August 24, 2015)
  • Z-2787-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N: 73124 Terum (August 24, 2015)