Stryker Instruments Div. of Stryker Corporation Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-501. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-501.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
Lot Numbers: 2008032504 through 2009022401.
Products Sold
Lot Numbers: 2008032504 through 2009022401.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, M due to The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended q. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
Recommended Action
Per FDA guidance
Stryker Instruments issued a recall letter dated June 16, 2009 and instructed Consignees to cease using and destroy the product and to return a business reply form for credit via fax to Stryker Instruments Regulatory Department, 1-866-521-2762. For further questions, contact Stryker Instruments at 1-800-800-4236 extension 3808.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026