Device recall

Z-1191-2009: Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5…

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

Key facts

Recall number (Z-number) Z-1191-2009
Recall event 51239
Product Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-25. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
Product code FRN
Recalling firm Stryker Instruments Div. of Stryker Corporation
Recall class Class II
Status Terminated
Termination date Dec 1, 2009
510(k) numbers K043466
FEI number 1811755

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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

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