Class 2 Device Recall PainPump2

• Date Initiated by Firm: September 02, 2010
• Date Posted: September 28, 2010
• Recall Status: Terminated on April 21, 2011
• Recall Number: Z-2592-2010
• Recall Event ID: 56695
• 510(K)Number: K042405 K043466
• Product Classification: Infusion Pump - Product Code FRN
• Product: Stryker PainPump2 400 mL PainPump with Luer Lock Tubing Set, sterile, REF 540-350, Stryker Instruments, Kalamazoo, MI. Delivers controlled amounts of medication and narcotics.
• Code Information: '09232012, '10112032, '09238012, '10113012, '09246012, '10116022, '09259012, '10117012, '09266012, '10118012, '09280012, '10119012, '09287012, '10120012, '09300012, '10123022, '09303012, '10124012, '10005012, '10153012, '10007012, '10154012, '10008012, '10155012, '10011012, '10158022, '10047012, '10159012, '10048012, '10160012, '10049012, '10161012, '10050012, '10162012, '10074022, '10165022, '10076012, '10166012, '10077012, '10167012, '10078012, '10167022, '10081022, '10168012, '10102022, '10169012, '10103012, '10170012, '10104012, '10172022, '10105012, '10173012, '10106012, '10174012, '10109022, '10175012, '10110012, '10176012, '10111022, and '10177012.
• 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: All of the failures lead to the patient receiving less medication than intended. Certain lots of the pain pump have a high failure rate associated with a cracked port housing which leads to internal or external leaks. Some lots have a high failure rate associated with E2 errors.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm sent our Urgent Medical Device Recall Notices dated 7/12/2010 to Risk Managers and Materials Managers. The recall notice listed specific lots of PainPump2 and PainPump2 BlockAid that were under recall. Consignees were told to check stock for the recalled product, quarantine the product, and contact Stryker to arrange return shipment of the recalled product. On 9/2/2010 the firm sent out a second Urgent Medical Device Recall Notice. This notice expanded the scope of the recall to include all products distributed within the past 12 months. The shelf life of the product is 1 year -so the recall was for all product currently in the supply chain. The letter again directed consignees to locate the recalled products and contact Stryker to arrange return shipment of the recalled product. The firm sent an additional letter dated 9/1/2010 to its customers. This letter stated that Stryker will no longer be offering any of their PainPump2 products.
• Quantity in Commerce: 54,568 all products
• Distribution: Worldwide 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.

• 510(K) Database: 510(K)s with Product Code = FRN; 510(K)s with Product Code = FRN