Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen Catheter and Luer Lock Tubing Set, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-158. The Stryker PainPump2 is an electromechanical pump designed to deliver a controlled amount of medication to the patient for pain management.
This recall has been terminated (originally issued April 30, 2009).
- Recall Initiated
- February 11, 2009
- Posted
- April 30, 2009
- Terminated
- December 1, 2009
- Recall Number
- Z-1184-2009
- Quantity
- 24,675 pumps
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
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 / Code Info
Lot Number: 08316012.
Root Cause
Process design
Action Taken
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.