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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PainPump2

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  Class 2 Device Recall Stryker PainPump2 see related information
Date Initiated by Firm February 11, 2009
Date Posted April 30, 2009
Recall Status1 Terminated 3 on December 01, 2009
Recall Number Z-1187-2009
Recall Event ID 51239
510(K)Number K043466  
Product Classification Pump, infusion - Product Code FRN
Product 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.
Code Information Lot Numbers: 08227012, 08239012, 08255012, 08275012, 08291012, 08296012 and 08304012.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Portage MI 49002-9704
For Additional Information Contact
800-800-4236 Ext. 4086
Manufacturer Reason
for Recall		 An electronic failure during preparation of the unit, or during patient use, may cause the pump to shut down.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = STRYKER INSTRUMENTS
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