Date Initiated by Firm |
June 21, 2021 |
Create Date |
August 16, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2305-2021 |
Recall Event ID |
88234 |
510(K)Number |
K200373
|
Product Classification |
Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
|
Product |
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
|
Code Information |
a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084 |
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 |
40,000 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 and Original Applicant = Delta Med Spa
|