Home / Recalls / Terumo Cardiovascular Systems Corp / Z-0949-2022

Z-0949-2022 Class II Terminated

Recalled by Terumo Cardiovascular Systems Corp — Ashland, MA

Recall Details

Product Type
Devices
Report Date
April 27, 2022
Initiation Date
February 3, 2022
Termination Date
February 20, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
64

Product Description

Cardiovascular Procedure Kit catalog # 76645 & 73806

Reason for Recall

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

Distribution Pattern

US Nationwide distribution in the states of CA and IN.

Code Information

[Lot #Z15957677, case label GTIN: (01)00699753507685, product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398, case label GTIN: (01)00699753477728, product identifier: (17)230228(10)Z16958398]

Other recalls by Terumo Cardiovascular Systems Corp

  • 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-2790-2015 Class II — Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077 (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)