CLASS II Device recall · Reported 28 Nov 2018 · FDA Enforcement Report
Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile recalled
LeMaitre Vascular is recalling Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile, distributed in Florida. The recall was initiated on 1 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0473-2019
- FDA event ID
- 81391
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2018
- FDA classified
- 16 Nov 2018
- Reported
- 28 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 1 Oct 2018 | Recall initiated by company | |
| 16 Nov 2018 | Classified by FDA | +46 days |
| 28 Nov 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pouches from this lot are not sealed compromising the sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
Where it was distributed
FL Foreign: Austalia, Korea
Questions about this recall
Why was it recalled?
Pouches from this lot are not sealed compromising the sterility
Which lots are affected?
LOT# PFP1055 Expiration Date: 2020-03-28
Where was it sold?
FL Foreign: Austalia, Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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