Point 4

Product Code - AC-0584D, lot number M446840

General and Plastic Surgery Devices

3

Yes

Class 3 Recall - Worldwide Distribution-- USA and Australia.

SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. || Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures.

Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia

Siemens RAPIDPoint 400 Measurement Cartridge || Siemens SMN numbers:10329756, 10341161

Serial Numbers:2610900214 through 2621001325. Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia

Siemens RAPIDPoint 405 Measurement Cartridge || Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

Software Versions prior to 3.5.1

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA and Australia, Austria, Bahamas, Barbados, Belgium, Bosnia Herzeg, Brazil, Canada, Canary Islands, Chile, Croatia, Czech Republic, Egypt, France, Germany, Holy See (Vatican City State) Hong Kong, Ireland, Italy, Japan, Macedonia, Malaysia, M¿xico, New Zealand Not assigned P.R. China, Poland, Portugal, Puerto Rico, Refurb.Systems U.S.A Republic Korea, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, U.A.E., United Kingdom

RapidPoint¿ 400 Analyzers for Blood Gas, Electrolytes and metabolites || Software Versions prior to 3.5.1. || The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

Software Versions prior to 3.5.1

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA and Australia, Austria, Bahamas, Barbados, Belgium, Bosnia Herzeg, Brazil, Canada, Canary Islands, Chile, Croatia, Czech Republic, Egypt, France, Germany, Holy See (Vatican City State) Hong Kong, Ireland, Italy, Japan, Macedonia, Malaysia, M¿xico, New Zealand Not assigned P.R. China, Poland, Portugal, Puerto Rico, Refurb.Systems U.S.A Republic Korea, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, U.A.E., United Kingdom

RapidPoint¿ 405 System Analyzers || The RP405 is capable of testing all of the analytes listed below including Co-Oximetry. || The Siemens 400 series system is intended for point of care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.