Lot numbers: HMO 9200  HMO 9217  HMO 9226  HMO 9232  HMO 9276  HMO 9285  HMO 9292 Exp. Date 1/2017

Hematology and Pathology Devices

2

No

Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.

Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. || Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

list 07-022 (TEG 5000), all serial numbers

Hematology and Pathology Devices

2

No

Nationwide Distribution including CA, FL, MD, PA, OH, SC, TN, TX, and VA

TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 || a multipurpose system for in vitro coagulation studies

part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011

Hematology and Pathology Devices

2

No

Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines

TEG Hemostasis System Level II Control: || Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series || Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System

All serial numbers

Hematology and Pathology Devices

1

No

Worldwide distribution: USA and countries including: Australia, Austria, AEU, Belgium, Bangladesh, Canada, China, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Singapore, Sri Lanka, Taiwan and Turkey.

2380 MINI Hand-Held Tube Sealer Power Source || (including a 23802000 Battery Pack) || The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials typically used in blood banks, blood processing facilities and transfusion centers.

Per recall strategy.

Hematology and Pathology Devices

2

No

US Nationwide

TEG 5000 Thromboelastograph Coagulation Analyzer || Product Usage: || Multipurpose System for In Vitro Coagulation Studies

All Serial numbers

Anesthesiology Devices

2

No

Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA

Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)

All serial numbers

Anesthesiology Devices

2

No

Worldwide distribution, including USA, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden.

Haemonetics cardioPAT Cardiovascular - autotransfusion System || Catalog Number: 02050-US

All lot numbers

Anesthesiology Devices

2

No

CA, MN, NE, TX

cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E || and Disposables: || cardioPAT Replacement RBC Bags, LN 00270 || cardioPAT Replacement Waste Bags, LN 00271 || cardioPAT Replacement Intraoperative Suction Set, LN 00272 || cardioPAT Replacement Postoperative Suction Set, LN 00273 || cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 || cardioPAT Replacement One-Way Valve Assembly LN 00275

All serial numbers

Anesthesiology Devices

2

No

Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.

Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System || Model 2050 US || Models Out-Side the US: || 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA || The Haemonetics¿ Cardiovascular Perioperative Autotransfusion System || for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical || procedures, where the expected rate of processing of salvaged blood and fluid || aspirated from the surgical site is less than or equal to two liters per hour.

Model 1: No Spill Collection System Serial numbers 00001 through 02279-T Model 2: Serial numbers beginning with 02280-T

Anesthesiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries including: Austria, Australia, Belgium, Switzerland, Canada, China, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Guatemala, Ireland, Israel, India, Italy, Japan, Lithuania, Luxembourg, Latvia, Monaco, Netherlands, Norway, Panama, Poland, Puerto Rico, Russian Federation, Saudi Arabia, Singapore, Slovak Republic, EI Salvador, Turkey and Taiwan.,

Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System || US Only: 1050-110-ENG || Outside US: || 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, || 1050-240-DUT, 1050-240-FRN, 1050-240-CZE, 1050-IIO-JPN. || Provides perioperative autotransfusion ( salvaging and reinfusing red blood cells (RBC's) from blood shed from patients undergoing orthopedic surgery. The portable system is used in operating rooms to recycle blood lost during surgery and in the recovery room to recycle blood lost after surgery. It can be transported to the patient floor for postoperative salvage.

Serial Numbers:  05F022-1; 05F023-1; 05H103;05C083-05C084; 05C087-05C089;05D006-05D011;05D037--05D040; 05D043-05D047;05D060-05D068;05D080--05D081; 05D085-05D089; 05E026-05E035;05E054-1; 05E055-1; 05E056;05E061-05E070; 05E091-05E095; 05F021; 05F066-05F072; 05F098-05F107;05F142-05F144; 05F147; 05F149; 05F150; 05F157-05F159;05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1; 05G057-05G059; 05G080-05G084;05H018; 05H022; 05H024- 05H027; 05H073-05H077; 05H100-05H101; 05H104; 05H163;  05J185-05J189; 05K011-05K013; 05K015--05K017; 05K092-05K096; 05K168-05K173 ; 05K175;  05K201

Anesthesiology Devices

2

No

Nationwide

Haemonetics Cell Saver 5+ Autogolous Blood Recovery System || Model Number: LN02005-110EP

Serial Numbers: 94H180CD-1; 95A048CS; 95J177CS

Anesthesiology Devices

2

No

Nationwide

Haemonetics Cell Saver 5 Autogolous Blood Recovery System || Model Numbr: LN02005-110-E

Single use autologous blood collection kit

medical_device

Single use autologous blood collection kit

Model: , Affected: RCB434KCE, 1756273, 1756274, 1746275, 1756276

Model: , Affected: Cell Saver 5/5+ Bowl Set - 70ml, Cell Saver Elite Processing Set - 70ml, Cell Saver 5/5+ Bowl Set - 70ml

md

md

md

md

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medical_device

medical_device

medical_device