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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 550 mL AutoFuser PainPump

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  Class 2 Device Recall Stryker 550 mL AutoFuser PainPump see related information
Date Initiated by Firm May 14, 2009
Date Posted September 04, 2009
Recall Status1 Terminated 3 on January 20, 2010
Recall Number Z-1851-2009
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, 10 mL/hr, sterile, REF 0535-100-000.
Code Information Lots 08136753321 through 09125932990.
Recalling Firm/
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 2
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 and Original Applicant = ACE MEDICAL US, LLC
510(K)s with Product Code = MEB and Original Applicant = ALGOS, LC