CODES: KH04103, KH04104, KH04105

General Hospital and Personal Use Devices

2

No

US Distribution in states of:OH, PA, AL, IL, TN, and CT.

0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 || Usage: Flush syringe.

KH03752

General Hospital and Personal Use Devices

2

No

Distributed to one customer in Illinois.

0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. || Flush syringe.

KH03752

General Hospital and Personal Use Devices

2

No

Distributed to one customer in Illinois.

0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. || Flush syringe.

Lots D316302 and D323912.

General Hospital and Personal Use Devices

2

No

CO, PA,

100 inch (254 cm) 15 Drop Administration Set with FlowSafe Flow Controller and Max Y Connector, 50 per box. Product No. MFS102

Lot Numbers:  13F17C0328 13F17F0296 13F17G0202 13F17H0104 13F17J0207

General Hospital and Personal Use Devices

2

No

US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM

10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501

Catalog/Model number CL-07011, Lot number CF03075226

General Hospital and Personal Use Devices

2

No

The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka

10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

309603 Syringe 5ML LL Syringe only 5067050; 309603 Syringe 5ML LL Syringe only 5062940

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

# 309603 -- Syringe 5Ml LL syringe.

309604 10 ML Syringe 5074833

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

#309604 -- 10 mL syringe

309604 Syringe 10 ML LL 5063484; 309604 Syringe 10 ML LL 5063495; 309604 Syringe 10 ML LL 5055564; 309604 Syringe 10 ML LL 5055567; 309604 Syringe 10 ML LL 5063493.

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

# 309604 -- Syringe 10 mL LL

309644 10 ml Syringe with 20 G1'' Needle 5033890

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

#309644 -- 10 ml syringe with 20 G1'' Needle

309661 Syringe only LL 20 ML 5061527; 309661 Syringe only LL 20 ML 5047172

General Hospital and Personal Use Devices

2

No

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

#309661 -- Syringe only ll 20 mL

Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL

General Hospital and Personal Use Devices

2

No

The product was distributed nationwide in the United States and worldwide.

3M Attest 1264P Biological Indicators, in boxes of 25 per box

Lot numbers 2005-07 DR, 2005-07 DS, 2005-07 DT, 2005-07 DU, 2005-08 DA, 2005-08 DB, 2005-08 DC, 2005-08 DN, and 2005-08 DO

General Hospital and Personal Use Devices

2

No

The product was distributed nationwide in the United States and worldwide.

3M Attest 1264 Biological Indicators, in boxes of 100 per box

Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29

General Hospital and Personal Use Devices

2

No

CA, MI, IL, MO, MN, GA, and Canada, Switzerland

3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)

Lot number 2006-12 AA through 2008-06 AB.

General Hospital and Personal Use Devices

2

No

Nationwide.

3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and February 28, 2003, were recalled.

General Hospital and Personal Use Devices

2

No

Procedure packs containing the drapes were shipped nationwide in United States.

3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ

3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ, which were contained in Cardinal Health Custom Procedure Packs sterilized between December 20, 2002 and February 28, 2003, were recalled.

General Hospital and Personal Use Devices

2

No

Procedure packs containing the drapes were shipped nationwide in United States.

3M Ioban 2 Antimicrobial Incise Drapes, Model 6651EZ

4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)Catalogue number: PR-05041-HPARTG Number: 148784

General Hospital and Personal Use Devices

Model Catalog: 35 (Lot serial: >10 NUMBERS CONTACT MFR)

General Hospital and Personal Use Devices

50MM 0.2 MICRON FILTER ATTACHMENT

Recorder Code 1400227

General Hospital and Personal Use Devices

1

No

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

7x10" Small Utility Positioner with Cover

Recorder Code 1400239

General Hospital and Personal Use Devices

1

No

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

9x15" Medium Utility Positioner with Cover

Product Codes: 8300-0168 ,8300-0169 ,8300-0157 ,8300-0158 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047,

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide

ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) || Product Usage: || The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.

General Hospital and Personal Use Devices

Medical Device Safety Alert: Baxa Abacus Total Parenteral Nutrition Calculation Software

General Hospital and Personal Use Devices

Medical Device Safety Alert: Baxter ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0

Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, and Taiwan.

ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.