—#79397

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K043466
Affected lot / code info: Lot Numbers: 08228012, 08240012, 08255012, 08270012 and 08277012.

Why it was recalled

An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Portage, Michigan 49002-9704

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-02-11
Posted by FDA: 2009-04-30
Terminated: 2009-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #79397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.