LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt — Class II medical device recall Z-0473-2019
Terminated recall by LeMaitre Vascular, Inc., reported 2018-11-28, distributed in FL. Pouches from this lot are not sealed compromising the sterility
| Recall number | Z-0473-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2018-10-01 |
| Classified | 2018-11-16 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2020-04-10 |
| Distributed | FL |
| Countries outside the US | KR |
| Quantity | 46 units |
| Reason classes | sterility |
| Lot numbers | PFP1055 |
| Model numbers | 2014-10 |
| Expiration dates | 2020-03-28 |
Product
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Reason for recall
Pouches from this lot are not sealed compromising the sterility
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-0473-2019. 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.