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Major Safety Alerts in December 2010

*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada Date of Issue (YYYY/MM/D Description of Product 2010/12/01 2010/12/01 DeRoyal NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE. Lot number: 22622679 SCC SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4. Fresenius LIBERTY Automated Peritoneal Dialysis System. PIN: 050-87212; 050-87215; 050-87216 Varian TrueBeam and TrueBeam STx, Model Number: TMX- H19. Units: H191001, H191003 Medtronic Navigation Vertex Max Drill Guide Source of Information* FDA FDA Reference No. by Source Z-0101-2011 Z-0102-2011 Z-0103-2011, Z-0104-2011, Z0105-2011 Alert Type by Source Class II Class II Local Agent N.A. N.A. Fresenius Medical Care Hong Kong Ltd. Varian Medical Systems Pacific Inc. Medtronic International, Ltd. Elekta Agent Contact Telephone No. N.A. N.A.

2010/12/01

FDA

Class II

2583 0813

2010/12/01

FDA

Z-0106-2011

Class II

2724 2836

2010/12/01

FDA

Z-0145-2011

Class II

2919 1362

2010/12/01

Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ

FDA

Z-0159-2011

Class II

2892 4323

2010/12/01

Edwards Lifesciences MHANM8 Pressure Slave Cable

FDA

Z-0160-2011

Class II

N.A. Siemens Healthcare Diagnostic Limited N.A. Biomet UK Ltd

N.A.

2010/12/01 2010/12/01 2010/12/01

Siemens Medical Solutions 550 TxT Patient Table (Part No. 7346534) Capintec Captus 3000 Thyroid Uptake System with Portable Stand Option (Capintec item no. 5430-2130) Biomet Microfixation 2.0/1.0 4 hole long plate (titanium plate). Lot 120150 Bio-Rad Laboratories in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001) Technidata TD-Synergy software (TD-SYN-01)

FDA FDA FDA

Z-0166-2011 Z-0167-2011 Z-0108-2011

Class II Class II Class II

2870 7533 N.A. N.A.

2010/12/01

FDA Technidata Medical Software Beckman Coulter Hong Kong Ltd MHRA

Z-0109-2011

Class II Firm Initiated Field Action Firm Initiated Field Action FSCA

Bio-Rad Pacific Ltd. Techidata Medical Software Beckman Coulter Hong Kong Ltd N.A.

2272 8926 (33) 0 4 7604 1300 2240 6150

2010/12/01

DR 26697

2010/12/02

Beckman Coulter Access Free T4 Calibrators REF 33885 Lot 014769

PCA-14964-2

2010/12/03

Leckey Mygo Seat used in conjunction with Otto Bock Discovery wheelbase

2010/011/025/301/001

N.A.

2010/12/03

Convatec Careline Easi-Mt Urine Bag

MHRA

2010/011/026/291/017

FSCA

N.A.

N.A.

2010/12/03

MediMark Europe Vitrea Enterprise Suite (VES) Version 1.2 and 1.3

MHRA

2010/011/025/291/010

FSCA

N.A.

N.A.

2010/12/03

AngioScore Angiosculpt® PTA Scoring Balloon Catheter, 0.018" OTW

MHRA

2010/011/024/291/001

FSCA

N.A.

N.A.

2010/12/06

Baxter Interlink Micro-Infusion Manifold. Model number: 2N3410 Synthes A) Synthes Modular Blade Plate System 50mm Spiral Blade B) Synthes Modular Blade Plate System 55mm Spiral Blade C) Synthes Modular Blade Plate System 60mm Spiral Blade D) Synthes Modular Blade Plate System 65mm Spiral Blade E) Synthes Modular Blade Plate System 70mm Spiral Blade F) Synthes Modular Blade Plate System 75mm Spiral Blade G) Synthes Modular Blade Plate System 80mm Spiral Blade H) Synthes Modular Blade Plate System 85mm Spiral Blade I) Synthes Modular Blade Plate System 90mm Spiral Blade J) Synthes Modular Blade Plate System 95mm Spiral Blade K) Synthes Modular Blade Plate System 100mm Spiral Blade L) Synthes Modular Blade Plate System 105mm Spiral Blade M) Synthes Modular Blade Plate System 110mm Spiral Blade N) Synthes Modular Blade Plate System 115mm Spiral Blade O) Synthes Modular Blade Plate System 120mm Spiral Blade Rocialle Rocialle Nhssc Xrd Swabs W.R. Grace & Co. Sodasorb CO2 Absorbent Ortho-Clinical Diagnostics Vitros Chemistry Products PHYT Slides Hospira A) Symbiq One Channel Infuser; B) Symbiq Two Channel Infuser Trumpf Medical Systems Ondal Acrobat 2000 Spring Arm Genzyme Diagnostics Cholesterol Assay, model 226-26, serial no. 37772 Pentron Clinical Technologies Build-It FR Mini Mix, model N32FA, Lot. 3519993, 3536336 Pentron Clinical Technologies A) Artiste Flowable B) Artiste Flowable Value Pack Medrad A) Avanta Fluid Injection System - Main unit with pedestal B) Avanta Fluid Injection System - Main unit with table mount

Health Canada

58316

Type II

Baxter Healthcare Ltd

2807 8555

2010/12/06

Health Canada

58438

Type II

Synthes (Hong Kong) Ltd

2724 2032

2010/12/06 2010/12/06 2010/12/06 2010/12/06 2010/12/06 2010/12/06 2010/12/06

MHRA Health Canada Health Canada Health Canada Health Canada Health Canada Health Canada

2010/011/016/081/010 58490 58683 58787 58576 58634 58682

FSCA Type II Type II Type II Type II Type III Type III

N.A. N.A. Ortho Clinical Diagnostics Hospira Limited N.A. N.A. N.A.

N.A. N.A. 2737 5504 2898 2886 N.A. N.A. N.A.

2010/12/06

Health Canada

58693

Type III

N.A.

N.A.

2010/12/06

Health Canada

58685

Type III

Prism Technologies Ltd.

2786 3233

2010/12/06

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