Recall archive
7 recalls · page 1 of 1
Reported Jul 6, 2022
Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand — When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2020
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand — Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from…
FDA (openFDA device enforcement)
Reported Feb 5, 2020
CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand — Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 6, 2019
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand · Product · Product details · Reason for recall — Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 5, 2018
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand · Product · Product details — OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 25, 2015
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand · Product · Product details — Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control…
FDA (openFDA device enforcement)
Reported Jul 31, 2013
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Haemonetics Corporation
Matched: Brand — Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
FDA (openFDA device enforcement)
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