Date Initiated by Firm | June 30, 2022 |
Create Date | August 18, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1557-2022 |
Recall Event ID |
90622 |
510(K)Number | K030688 K093750 |
Product Classification |
Catheter, continuous flush - Product Code KRA
|
Product | Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only |
Code Information |
Lot # B262322 UDI: (00) 847536005983 |
Recalling Firm/ Manufacturer |
Micro Therapeutics, Inc. 9775 Toledo Way Irvine CA 92618-1811
|
For Additional Information Contact | Kelli Lynch 203-500-3328 |
Manufacturer Reason for Recall | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On June 30, 2022, Micro Therapeutics, Inc. issued a "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" to affected customers. The recall notification ask consignees to take the following actions:
1. Do NOT use any impacted product. Remove and quarantine all unused impacted product in your inventory.
2. Return the impacted products to Medtronic. Your Medtronic representative may assist in facilitating the return of product, as necessary. If alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product.
3. Complete and return the Customer Confirmation Form enclosed in this letter acknowledging that you have received this information.
4. This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action.
5. Adverse reactions or quality problems experienced with this product should be reported to Medtronic and FDA MedWatch Adverse Event Reporting program via:
" Medtronic Quality Assurance at rs.nvcomplaints@medtronic.com or call +1 (763) 514-4000 (Worldwide)
" The FDA website (http://www.fda.gov/Safety/MedWatch/HowtoReport/default.htm) or call FDA at 1-800-FDA-1088. |
Quantity in Commerce | 2 units |
Distribution | US Nationwide Distribution: None
OUS: Brazil |
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 = KRA 510(K)s with Product Code = KRA
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