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U.S. Department of Health and Human Services

Class 2 Device Recall Easypump

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  Class 2 Device Recall Easypump see related information
Date Initiated by Firm January 17, 2006
Date Posted March 07, 2006
Recall Status1 Terminated 3 on February 05, 2007
Recall Number Z-0584-06
Recall Event ID 34494
510(K)Number K932740  K052117  
Product Classification Pump, Infusion, Elastomeric - Product Code MEB
Product Easypump ST 100-1 infusion pump
Code Information lot 562791
Recalling Firm/
Manufacturer		 I-Flow Corporation
20202 Windrow Dr
Lake Forest CA 92630-8152
For Additional Information Contact Shane Noehre
949-202-2653
Manufacturer Reason
for Recall		 The sterile pack may contain the wrong infusion pump inside.
FDA Determined
Cause 2		 Other
Action The affected customer has been notified with a Notification letter dated January 17, 2006 via e-mail of Recall Notification Letter, with follow-up confirmation e-mails.
Quantity in Commerce 630
Distribution France only
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 = BLOCK MEDICAL, INC.
510(K)s with Product Code = MEB and Original Applicant = I-FLOW CORP.
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