| Class 2 Device Recall Stryker PainPump2 | |
Date Initiated by Firm | February 11, 2009 |
Date Posted | April 30, 2009 |
Recall Status1 |
Terminated 3 on December 01, 2009 |
Recall Number | Z-1183-2009 |
Recall Event ID |
51239 |
510(K)Number | K043466 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | Stryker PainPump2, 250 mL PainPump with Luer Lock Tubing Set, 5.0 inch ExFen and Standard Catheter, 5 per box, sterile, Stryker, Kalamazoo, MI; REF 525-155.
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: 08228012, 08236012, 08249012, 08259012, 08268022, 08271012, 08273022, 08297012, 08315022, 08323012, 08324012 and 08344012. |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E. Milham Ave. Portage MI 49002-9704
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FRN
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