Recall Z-2312-2013— Atrium Medical Corporation

Name: FDA recall Z-2312-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-12

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2013-07-12, terminated 2014-07-15. It names one FDA 510(k) clearance: K000504. Product: Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.. Reason: Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field.

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-07-12
Terminated: 2014-07-15
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K000504 — ADVANTA SUPER SOFT GRAFTAtrium Medical Corp.·cleared 2000-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.