Advanta VS Grafts <6mm Intended for use in arterial vascular… — Class II medical device recall Z-2309-2013
Terminated recall by Atrium Medical Corporation, reported 2013-10-09, distributed nationwide. Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile
| Recall number | Z-2309-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Hudson, NH, United States |
| Recall initiated | 2013-07-12 |
| Classified | 2013-09-30 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BO, BR, CA, CH, CL, CO, DE, EG, ES, FI, FR, GB, GR, GT, HK, ID, IE, IN, IT, JM, JP, KR, LB, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, RU, SA, SG, SI, SV, TH, TN, TT, TW, ZA |
| Reason classes | labeling, sterility |
Product
Advanta VS 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2309-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.