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 | K052117 K932740 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = MEB 510(K)s with Product Code = MEB
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