FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-250.
- Recall number
- Z-1748-2009
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-250.
- 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
- 244
- 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
- Lot Numbers: 2007020701 through 2008120303.
- 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
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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 b87518bfe2e8, published 2026-09-28