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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 16, 2010
Date Posted October 20, 2010
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-0098-2011
Recall Event ID 56687
Product Classification Pump, Infusion - Product Code FRN
Product Stryker PainPump2 blockAid 400 mL Painpump for continuous Nerve Block, REF 575-100, Sterile, Rx only, Stryker Instruments, Kalamazoo, MI.
Code Information '09049012, '09152022, '09168012, '09169012, '09170012, '09171012, '09173032, '09174012, '09175012, '09177012, '09178012, '09180022, '09201022, '09202012, '09204012, '09205012, '09209012, '09210012, '09212012, '09215012, '09216012, '09218012, '09219012, '09220012, '09222022, '09224012, '09225012, '09226012, '09229022, '09231012, '09233012, '09236022, '09237012, '09239022, '09243022, '09244012, '09245012, '09247012, '09252022, '09253012, '09254012, '09257022, '09260012, '09261012, '09264022, '09265012, '09268012, '09268022, '09271022, '09274012, '09275012, '09278022, '09279012, '09281012, '09282012, '09285022, '09286012, '09287012, '09288012, '09294012, '09295012, '09296012, '09299022, '09300012, '09302012, '09303012, '09306022, '09307012, '09343022, '09344012, '09345012, '09346012, '09348022, '09349012, '09350012, '09351012, '09352012, '09355012, '09356012, '09357012, '09362012, '09363012, '09364012, '10004022, '10005012, '10008012, '10011022, '10012012, '10013012, '10015012, '10019012, '10020012, '10021012, '10022012, '10025012, '10026012, '10027012, '10028012, '10041022, '10042012, '10043022, '10048012, '10049012, '10053022 and '10054022.  
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact Jennifer Mars
269-323-7700
Manufacturer Reason
for Recall		 The instructions for use (IFU) has been revised for health care professionals. The indication for use has been changed to remove site specific pain management. The firm has revised the warning to not use the pump around joint spaces. A warning has been added regarding the use of the pump with anticoagulants in epidural applications. A special reminder to users to always evaluate the potential
FDA Determined
Cause 2		 Other
Action Stryker Instruments sent Urgent Medical Device Recall Notification letters dated 8/16/2010 to healthcare professionals. The recall letters outlined the changes for the instructions for the use of these products. The letters informed the healthcare professional to review the new IFU, to distribute the new IFU to all healthcare professionals that use the device, and to complete and return the business reply form. The letters included a complete IFU that was to be used with any remaining stock of devices. Customers should dispose of the old version of the IFU. There is no product being returned for this recall.
Quantity in Commerce 11,976 all products
Distribution US, Canada and Australia.
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.
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