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U.S. Department of Health and Human Services

Class 2 Device Recall NEO DELTA Self Safe 1

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  Class 2 Device Recall NEO DELTA Self Safe 1 see related information
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 and Original Applicant = DELTA MED SRL
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