Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522

FDA Recall Z-2301-2021 · Posted None

Recalling FirmDelta Med SpA
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2021-06-21
Product Quantity20,000 units

Reason for Recall

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

Firm Action

The firm disseminated the notices on 06/21/2021 by email. The firm is requesting destruction of the affected devices at the consignee.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of FL and MN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121007NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1Delta Med Srl · 2012-12-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑