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.

Terminated

UltraSafe Dental Needle Guard, P/N: 401801 Lot:T20201501

FDA Recall Z-0444-03 · Posted 2003-01-14

Recalling FirmSafety Syringes Inc
Recall StatusTerminated
Product CodeMEG
Date Initiated2002-09-05
Date Terminated2003-12-03
Product Quantity3300

Reason for Recall

Package integrity not validated. Sterility not assured.

Firm Action

Firm initiated recall on 9/5/2002. Visits, telephone calls and letters were the tools used to implement the recall. Unused recalled units were retrieved from customers. This recall is complete.

Root Cause

Other

Distribution Pattern

Medical offices located in California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013801ULTRASAFE DENTAL INJECTION SYSTEMSafety Syringes, Inc. · 2001-12-13

Official Source

View FDA Recall →

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

↑