CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Anastoclip AC 35 Clips (1 Each} Medium recalled by LeMaitre Vascular
LeMaitre Vascular is recalling Anastoclip AC 35 Clips (1 Each} Medium, distributed nationwide in the US. The recall was initiated on 22 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2283-2016
- FDA event ID
- 74563
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jun 2016
- FDA classified
- 25 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Jun 2016 | Recall initiated by company | |
| 25 Jul 2016 | Classified by FDA | +33 days |
| 3 Aug 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Anastoclip AC 35 Clips (1 Each} Medium recalled?
Yes. LeMaitre Vascular recalled Anastoclip AC 35 Clips (1 Each} Medium on 22 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2283-2016.
Why was it recalled?
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
Which lots are affected?
Lot Numbers: ANC1532¿ ANC1577¿ ANC1643¿ ANC1647¿ ANC1673¿ ANC2007¿ ANC2025¿ ANC2027¿ ANC2031¿ ANC2032¿ ANC2037¿
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LeMaitre Vascular
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
| Device | CLASS II | Artegraft¿ Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | AR |
| Device | CLASS II | Artegraft Collagen Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Labeling Errors | Nationwide |
| Device | CLASS II | Artegraft Collagen Vascular Grafts recalled by LeMaitre Vascular | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Pruitt Irrigation Occlusion Catheter recalled by LeMaitre Vascular | LeMaitre Vascular | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |