Terminated

Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

FDA Recall Z-2311-2013 · Posted 2013-09-30

Recalling FirmAtrium Medical Corporation

Recall StatusTerminated

Product CodeDSY

Date Initiated2013-07-12

Date Terminated2014-07-15

Reason for Recall

Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field

Firm Action

Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at [email protected]

Root Cause

Package design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010516ADVANTA SST GRAFT (>_6MM)Atrium Medical Corp. · 2001-05-18

Official Source

View FDA Recall →

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