Class 2 Device Recall Stryker PainPump

• Date Initiated by Firm: February 03, 2006
• Date Posted: March 21, 2006
• Recall Status: Terminated on June 04, 2007
• Recall Number: Z-0667-06
• Recall Event ID: 34545
• 510(K)Number: K042405
• Product Classification: Pump, Infusion, Pca - Product Code MEA
• Product: Stryker PainPump1 2-Site Y-Connector; Product number 500-250-000.
• Code Information: Lot 2005053102.
• 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: The catheter tubing included in the kit may break during removal.
• FDA Determined Cause: Other
• Action: Each consignee was notified of the recall via recall letter dated 2/7/06, which requested that they destroy the affected lots on site. International accounts were notified via email.
• Distribution: Nationwide, Australia 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 = MEA