Date Initiated by Firm | June 21, 2021 |
Create Date | August 16, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2300-2021 |
Recall Event ID |
88234 |
510(K)Number | K121007 |
Product Classification |
Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
|
Product | NEO DELTA Self Safe 1, I.V. Catheter with PUR
REF 3708122, Lot 00A1160627
5000 units |
Code Information |
REF 3708122, Lot 00A1160627 |
Recalling Firm/ Manufacturer |
Delta Med SpA Via Guido Rossa 20 Viadana Italy
|
Manufacturer Reason for Recall | Problems related to the sterilization of the medical devices; possible missing sterility of the medical device |
FDA Determined Cause 2 | Process control |
Action | The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee. |
Quantity in Commerce | 5000 units |
Distribution | US Nationwide distribution in the states of FL and MN. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = FOZ
|