Recall Z-1187-2009 ยท FRN Pump, Infusion
Stryker Instruments Div. of Stryker Corporation
Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2 Site Catheter Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 540-50. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
| Date | Apr 30, 2009 (initiated Feb 11, 2009) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043466 | PAINPUMP2 Stryker Instruments, May 10, 2005 |