Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC… — Class II medical device recall Z-2285-2016
Terminated recall by LeMaitre Vascular, Inc., reported 2016-08-03, distributed nationwide. US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be u
| Recall number | Z-2285-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2016-06-22 |
| Classified | 2016-07-25 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2021-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 170 units |
| Model numbers | 4000-08 |
Product
Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Reason for recall
US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use.
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-2285-2016. 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.