FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-156, REF 525-157 and REF 525-158.
- Recall number
- Z-1763-2009
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-156, REF 525-157 and REF 525-158.
- Status
- Terminated
- Initiated
- 2009-06-16
- Posted
- 2009-08-19
- Terminated
- 2010-10-27
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 106
- Distribution
- Worldwide Distribution -- Including the United States, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Sweden, Switzerland and Taiwan.
- Lot, serial or model codes
- REF 525-156, Lot Numbers: 08113012 through 08365012; REF 525-157, Lots Numbers: 08127012 through 09092012 and REF 525-158, Lot Numbers: 08049012 through 09082012.
- 510(k) numbers
- K042405, K043466
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06