Date Initiated by Firm | December 18, 2008 |
Date Posted | September 21, 2009 |
Recall Status1 |
Terminated 3 on October 27, 2011 |
Recall Number | Z-2113-2009 |
Recall Event ID |
50687 |
510(K)Number | K031199 |
Product Classification |
Enteral Infusion Pump - Product Code LZH
|
Product | Infinity Orange Enteral Feeding Pump, REF INFORNG, Zevex Enteral Nutrition Delivery Systems, Salt Lake City, UT 84123. |
Code Information |
Serial numbers in range: 607129001 - 608275026 |
Recalling Firm/ Manufacturer |
Zevex International, Inc. 4314 Zevex Park Ln Salt Lake City UT 84123
|
For Additional Information Contact | 801-264-1001 |
Manufacturer Reason for Recall | Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing. |
FDA Determined Cause 2 | Software design (manufacturing process) |
Action | All of Zevex' customers and distributors were notified by an Urgent Medical Device Correction letter, dated 12/18/2008. The letters explained the issue, the patient impact, and what necessary actions should be taken. Customers were instructed to contact Zevex to schedule the upgrade of their installed base of pumps at 800-970-2337 or sales@zevex.com. Distributors were to contact their customers and notify them of the letter. |
Quantity in Commerce | 318 |
Distribution | Nationwide, including 1 VA facility in CA. Foreign distribution to 1 consignee in Canada. |
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 = LZH
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