LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying recall: Sterility Concern
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Why was LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying recalled?
Pouches from this lot are not sealed compromising the sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
LOT# PFP1055 Expiration Date: 2020-03-28
- Product
- LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 46 units
- Distribution
- FL Foreign: Austalia, Korea
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)