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Terminated

CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)

FDA Recall Z-0008-2008 · Posted 2007-10-04

Recalling FirmLemaitre Vascular, Inc.
Recall StatusTerminated
Product CodeDXT
Date Initiated2007-07-18
Date Terminated2008-09-08
Product Quantity7,860 units

Reason for Recall

Sterility of device may be compromised due to breach in sterile barrier.

Firm Action

The firm issued a "Adivsory Notice" to accounts 7/18/07, advising them to examine inventory and remove product with defective packaging. The firm issued an updated notification dated 9/24/07 advising users to return recalled lots instead of conducting an examination of the product at the user site.

Root Cause

Package design/selection

Distribution Pattern

Worldwide, including USA, Canada, Netherlands, and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973334OZ POWER SYRINGECardiovascular Innovations · 1998-04-03

Official Source

View FDA Recall →

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

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