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

Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010

FDA Recall Z-0963-03 · Posted 2003-07-02

Recalling FirmMedAmicus,Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2003-06-06
Date Terminated2004-07-02
Product Quantity14 units

Reason for Recall

Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications.

Firm Action

The consignees were sent recall letters, dated June 6, 2003 or June 20, 2003, that requested the return of the products.

Root Cause

Other

Distribution Pattern

The products were distributed to 4 consignees in Georgia, Missouri, New York and North Carolina. Most of the product was shipped to a distributor in New York which probably shipped to other states. There was no direct distribution to foreign or U.S Government accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021044MADETTWolfe Tory Medical, Inc. · 2002-09-11

Official Source

View FDA Recall →

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

↑