LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts
LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where the packaging failure compromises sterility, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 46 units of the Pruitt F3-S Polyurethane Outlying Carotid Shunt, Sterile, Model # 2014-10. The recall is being conducted because the pouches from this specific lot are not sealed, which compromises the sterility of the medical devices.
The affected lot number is PFP1055, with an expiration date of March 28, 2020. The distribution pattern indicates that the products were distributed in Florida and to foreign locations including Australia and Korea.
Healthcare providers and facilities that have received these devices should stop using them and contact LeMaitre Vascular for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Shunt
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT# PFP1055 Expiration Date: 2020-03-28
Distribution
Distributed in 1 state:
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