Home / Recalls / Terumo Cardiovascular Systems Corp / Z-0160-2015

Z-0160-2015 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: 16579 ; Catalog 6375: 3256 units

Product Description

Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.

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: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0. Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3 Manufacturing dates March 15, 2010 through December 13, 20 I 0

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-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)
  • Z-2790-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077 (August 24, 2015)
  • Z-2786-2015 Class II — Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Car (August 24, 2015)