RecallRadar

FDA Device recall Z-2317-2013

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

On 2013-10-09 the FDA classified a Class II recall of Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access by Atrium Medical, citing inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2317-2013
ClassificationClass II
Statusterminated
Initiated2013-07-12
Published2013-10-09
Last updated2026-09-13 11:53 UTC
CompanyAtrium Medical
DistributionUS

Product

Advanta SST 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

Identifiers

code_infoProduct manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2317-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.