Class 2 Device Recall Stryker PainPump

• Date Initiated by Firm: November 07, 2008
• Date Posted: February 02, 2009
• Recall Status: Terminated 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: 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