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U.S. Department of Health and Human Services

Class 2 Device Recall PainPump2

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  Class 2 Device Recall PainPump2 see related information
Date Initiated by Firm September 02, 2010
Date Posted September 28, 2010
Recall Status1 Terminated 3 on April 21, 2011
Recall Number Z-2591-2010
Recall Event ID 56695
510(K)Number K043466  K042405  
Product Classification Infusion Pump - Product Code FRN
Product Stryker PainPump2 250 mL PainPump with Luer Lock Tubing Set, sterile, REF 525-350, Stryker Instruments, Kalamazoo, MI.

Delivers controlled amounts of medication and narcotics.

Code Information '09234012, '09241012, '09246012, '09258012, '09262012, '09283012, '09289012, '09290012, '09292022, '10012012, '10013012, '10014012, '10015012, '10018022, '10019012, '10021012, '10028012, '10029012, '10032022, '10033012, '10039022, '10040012, '10152022, '10153012, '10188012, and '10203012.  
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact Jennifer Mars
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 2
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 and Original Applicant = STRYKER CORP.
510(K)s with Product Code = FRN and Original Applicant = STRYKER INSTRUMENTS