Lot Numbers:  13F17D0240 13F17G0371 13F17K0408

Anesthesiology 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

0.2 Micron Flat Epidural Filter; Product Code: EF-05500

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

Item #00-2568-000-10; Lot #62800843

General and Plastic Surgery Devices

1

No

Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.

Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. || Intended for post-operative collection of wound drainage.

All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11-S.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

10.5CM ANGLE ATTACHMENT, BLACK MAX

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-S.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

10.5cm Long Attachment || Product Usage: || Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-01.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

10.5cm Long Attachment, Non-Tapered End || Product Usage: || Pneumatic system

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11-S.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

10.5cm QD Angle Attachment || Product Usage: || Pneumatic system

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

Product Code: C4320-450B Lot Number: 300403

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Cardinal Health Prefilled Buffered 10% Formalin. || Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Product Code: 426-796 Lot Number: 298987

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Protocol 10% NBF || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Product Code: 534801 Lot Number: 296986

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Richard-Allan Scientific Specimen Transportation System. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Product Code: LC-0060 Lot Number: 300445

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Richard-Allan Scientific 10% Neutral Buffered Formalin. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Product Code: 59601 Lot Number: 300233

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Richard-Allan Scientific Bio-Tite Specimen Containers. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Product Code: 51401 Lot Number: 300649

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Richard-Allan Scientific 10% Neutral Buffered Formalin. || Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Product Code: 53151 Lot Number: 300143

Hematology and Pathology Devices

1

No

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.

Richard-Allan Scientific Specimen Transportation System. || 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

Lot #6000 (Serial numbers: 1480 thru 1489); Lot #6058 (Serial numbers: 1490 thru 1493 and 1534 thru 1539); & Lot #6155 (Serial numbers: 1540 thru 1559).

General and Plastic Surgery Devices

1

No

World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.

Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1104; manufactured by Lone Star Medical Products, Inc.

Lot #5869 (Serial numbers: 5193 thru 5200, 5207 thru 5211 and 5213 thru 5229); Lot #5924 (Serial numbers: 5244, 5245, 5254, 5256 thru 5260, 5169, 5172, 5181, 5152, and 5185 thru 5187); & Lot #5982 (Serial numbers: 5148, 5176, 5183, 5184, 5188, 5192, 5204, 5206, 5253 and 5255).  Serial numbers: , ;

General and Plastic Surgery Devices

1

No

World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.

Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.

Lot #5868 (Serial numbers: 7558 thru 7565); Lot #5890 (Serial numbers: 5230 thru 5243 and 7548) & Lot #5923 (Serial numbers: 7533, 7536, 7539, 7543 thru 7545, 7548 and 7549).

General and Plastic Surgery Devices

1

No

World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.

Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, model #1110; manufactured by Lone Star Medical Products, Inc.

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

11.0cm Long Attachment || Product Usage: || Pneumatic system

All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLUE-S.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

11.25CM ATTACHMENT, BLACK MAX

Model 233, Serial Numbers 061-3-00001 through 101-3-01389 and Model 25-01, Serial Numbers 073-CB-00001 through 094-CB-00138.

Cardiovascular Devices

2

No

Worldwide Distribution -- US, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, & WI and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, CHILE, CROATIA, ECUADOR, EL SALVADOR, GERMANY, HONG KONG, INDONESIA, ISRAEL, ITALY, KOREA, MALAYSIA, MEXICO D.F., NEW ZEALAND, PEOPLE'S REPUBLIC OF CHINA, PERU, REPUBLIC OF SIGNAPORE, SPAIN, TAHITI, THAILAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY & VENEZUELA.

115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolBlue Model 25-01 Hyper/Hypothermia System, Part number: 86000. || Used to lower or to raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.