Stryker PainPump2, 250 mL Pre-Set PainPump with Luer Lock Tubing Set, 2.5 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 521-125. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
FDA Recall Z-1189-2009 · Posted 2009-04-30
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2009-02-11
Date Terminated2009-12-01
Product Quantity24,675 pumps
Reason for Recall
An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
Firm 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.
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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