Device recall

Z-1322-2010: Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare…

FDA device recall · Class II · Baxter Healthcare Renal Div

Key facts

Recall number (Z-number) Z-1322-2010
Recall event 54373
Product Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
Product code FKP
Recalling firm Baxter Healthcare Renal Div
Recall class Class II
Status Terminated
Termination date Feb 3, 2011
510(k) numbers K883111, K922757
FEI number 3000210122

At a glance

  • 1–9 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)