Device recall

Z-0913-2011: Stryker Instruments, SmartPump Tourniquet System, Single Channel Tourniquet…

FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation

Key facts

Recall number (Z-number) Z-0913-2011
Recall event 56624
Product Stryker Instruments, SmartPump Tourniquet System, Single Channel Tourniquet Pump, REF 5920-010-000, Rx only, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. Intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical…
Product code KCY
Recalling firm Stryker Instruments Div. of Stryker Corporation
Recall class Class II
Status Terminated
Termination date May 16, 2011
510(k) numbers K924273
FEI number 1811755

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)