FDA Device Recall Z-0008-2008: Lemaitre Vascular, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-2008.

Recall Res Number

Z-0008-2008

Recalling Firm / Manufacturer

Lemaitre Vascular, Inc.

FEI Number

1220948

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-07-18

Date Posted

2007-10-04

Date Terminated

2008-09-08

Product Code

DXT

Event Number

38894

Product Quantity

7,860 units

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

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

Action Details 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.

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

Code Information / Serial Numbers Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.

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Medical Device Recall: Z-0008-2008

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer