Class II — LeMaitre Vascular, Inc.
| Recalling firm | LEMAITRE VASCULAR, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Pouches from this lot are not sealed compromising the sterility |
| Product | LeMaitre Vascular Pruitt F3®-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 |
| Quantity | 46 units |
| Distribution | FL Foreign: Austalia, Korea |
| Initiated | 2018-10-01 |
| Classified | 2018-11-16 |
| Terminated | 2020-04-10 |
| Recall number | Z-0473-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LeMaitre Vascular, Inc. (Z-0473-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81391/
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