Class 2 Device Recall Stryker 550 mL AutoFuser PainPump

• Date Initiated by Firm: May 14, 2009
• Date Posted: September 04, 2009
• Recall Status: Terminated on January 20, 2010
• Recall Number: Z-1866-2009
• Recall Event ID: 52163
• 510(K)Number: K041585 K060258
• Product Classification: Infusion pump for pain medication. - Product Code MEB
• Product: Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, 60 minute bolus refill, 1 x 2.5 in. catheter, sterile, REF 0535-626-025.
• Code Information: Lots 08142755414 through 08177769553.
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E. Milham Ave.; Kalamazoo MI 49001
• For Additional Information Contact: 800-800-4236 Ext. 3808
• Manufacturer Reason for Recall: Failure to infuse and potential compromised sterility: The seal on the tyvek tray cover may fail, compromising sterility, and the device may fail to infuse the drug, resulting in a loss of pain mitigation.
• FDA Determined Cause: Process control
• Action: Stryker sent all consignees a Medical Device Recall Notification letter dated 5/14/09 and instructed to locate and destroy the recalled products and to complete and return the business reply card.
• Quantity in Commerce: 28,755 of all pumps
• Distribution: Nationwide and Canada.
• 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 = MEB; 510(K)s with Product Code = MEB