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

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

FDA Recall Z-2305-2021 · Posted None

Recalling FirmDelta Med SpA
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2021-06-21
Product Quantity40,000 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.

K200373Deltaven Fast Flash Closed I.V. Catheter SystemsDelta Med Spa · 2020-08-26

Official Source

View FDA Recall →

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

↑