Device recall

Z-0616-2011: Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in…

FDA device recall · Class I · Fresenius Kabi, LLC

Key facts

Recall number (Z-number) Z-0616-2011
Recall event 57290
Product Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic…
Product code LKN
Recalling firm Fresenius Kabi, LLC
Recall class Class I
Status Terminated
Termination date Oct 5, 2011
FEI number 3007344667

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)