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Terminated

50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.

FDA Recall Z-1625-2012 · Posted 2012-05-17

Recalling FirmMEDDEV USA, INC.
Recall StatusTerminated
Product CodeKDH
Date Initiated2012-05-10
Date Terminated2013-08-15
Product Quantity20 units

Reason for Recall

The device was marketed without a 510(k) and is not sterile.

Firm Action

MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV . For questions regarding this recall call 214-692-3559.

Root Cause

No Marketing Application

Distribution Pattern

Nationwide Distribution including Illinois

Official Source

View FDA Recall →

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

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