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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PainPump

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  Class 2 Device Recall Stryker PainPump see related information
Date Initiated by Firm November 07, 2008
Date Posted February 02, 2009
Recall Status1 Terminated 3 on December 01, 2009
Recall Number Z-0925-2009
Recall Event ID 50184
510(K)Number K042405  
Product Classification Pump, infusion - Product Code FRN
Product Stryker PainPump Two Site Infusion Set, sterile, 10 per box. Manufactured for Stryker Instruments, Kalamazoo, MI. Product number 0500-200-000, REF 500-200.

A disposable syringe infuser which uses sustained vacuum pressure to deliver a continuous infusion of medications or fluids at a controlled rate. It delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. It is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.
Code Information Lot Number: 2008011601, 2008040204 and 2008061801.
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. 3808
Manufacturer Reason
for Recall		 There is a potential for the pump to overinfuse.
FDA Determined
Cause 2		 Process control
Action A "Medical Device Recall Notification" letter dated November 11, 2008 was issued to consignees. The letter identified the problem and instructed consignees to locate and destroy all affected products. Customers were also instructed to complete the enclosed Business Reply form and fax it to Stryker Instruments Regulatory Department at 866-521-2760. For questions regarding the recalled product, contact Stryker Instruments at 1-800-800-4236, extension 4056 or extension 3808.
Quantity in Commerce 118 boxes of all products.
Distribution Nationwide Distribution.
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 CORP.
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