Date Initiated by Firm | May 03, 2019 |
Create Date | June 15, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1786-2019 |
Recall Event ID |
82828 |
510(K)Number | K132547 |
Product Classification |
Calculator, drug dose - Product Code NDC
|
Product | Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. |
Code Information |
Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10 |
Recalling Firm/ Manufacturer |
Monarch Medical Technologies 2137 South Blvd Ste 300 Charlotte NC 28203-5189
|
For Additional Information Contact | Bruce Lisanti 855-363-7475 |
Manufacturer Reason for Recall | Insulin dosing calculations were erroneously high. |
FDA Determined Cause 2 | Software change control |
Action | The firm notified the consignees by email beginning on 05/03/2019. The notice alerted the consignee of the problem and provided an educational brief and a tip card to provide to the staff to remind them to always use clinical judgement in following EndoTool IV dose recommendations. |
Quantity in Commerce | 83 downloads |
Distribution | Nationwide and Dubai |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = NDC
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