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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker PainPump

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  Class 2 Device Recall Stryker PainPump see related information
Date Initiated by Firm February 03, 2006
Date Posted March 21, 2006
Recall Status1 Terminated 3 on June 04, 2007
Recall Number Z-0668-06
Recall Event ID 34545
510(K)Number K042405  
Product Classification Pump, Infusion, Pca - Product Code MEA
Product Stryker PainPump1.5 Base Infusion Kit; Product number 501-100-000.
Code Information Lot 2005053004.
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 2
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 and Original Applicant = STRYKER CORP.
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