Device recall

Z-2220-2025: Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage…

FDA device recall · Class II · INSTITUT GEORGES LOPEZ

Key facts

Recall number (Z-number) Z-2220-2025
Recall event 96793
Product Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts…
Product code MSB
Recalling firm INSTITUT GEORGES LOPEZ
Recall class Class II
Status Open, Classified
510(k) numbers K991594
FEI number 3024820181

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)