FDA Device recall Z-1054-2013
LeMaitre Stent Guide: 1102-00 (100 strips)
- FDA Device
- Class II
- terminated
- Published 2013-04-10
On 2013-04-10 the FDA classified a Class II recall of LeMaitre Stent Guide: 1102-00 (100 strips) by Lemaitre Vascular, citing devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1054-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-18 |
| Published | 2013-04-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lemaitre Vascular |
| Distribution | US |
Product
LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
Reason
Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
Identifiers
| code_info | LSG1130, exp. 2017-04; LSG1132, exp. 2017-11 |
|---|
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-1054-2013%22
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