FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
- Recall number
- Z-1192-2009
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
- Status
- Terminated
- Initiated
- 2009-02-11
- Posted
- 2009-04-30
- Terminated
- 2009-12-01
- Reason
- An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
- Root cause
- Process design
- Action
- A "Medical Device Recall Notification" letter dated February 11, 2009 was issued to consignees via phone, mail and/or email. The letter described the issue and instructed customers to discontinue use of the recalled product, destroy it according to instructions provided with the notification and return the "Business Reply Form" by fax to Stryker Instruments Regulatory Department, 1-866-521-2762. Further questions should be addressed to Stryker Instruments at 1-800-800-4236 extension 4086.
- Quantity
- 24,675 pumps
- Distribution
- Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, WI, WV and WY and countries of Argentina, Australia, Brazil, Canada, England, Singapore and South Africa.
- Lot, serial or model codes
- Lot Numbers: 08228012, 08240012, 08255012, 08270012 and 08277012.
- 510(k) numbers
- ["K043466"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1811755
- Firm city
- Portage
- 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