Lot Numbers:  AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.

General and Plastic Surgery Devices

Unclassified

No

US nationwide distribution.

Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03

Lot BMZCE039, Expiration Date 2018-12-31

Gastroenterology-Urology Devices

Unclassified

No

Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.

X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 || The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.

Version: 23.1.2, 23.2.0, 25.0.0, 25.1.0, 25.2.0, 25.3.0

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

SCC Soft Computer Softbank II software || Product Usage: || Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, test and transfusion history, transfusion management, inventory management, product distribution, and final disposition are all monitored using the software.

Version: 35.5.2.0, 25.5.3.0, 25.5.3.1

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

Softbank software || Product Usage: || Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.

Versions 6.1 and 6.5

General Hospital and Personal Use Devices

Unclassified

No

Software was distributed to end users nationwide and internationally.

BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Labeled in part ***Varian Medical Systems Inc. Oncology Systems***

Lot 050-779, Model # 1523211; Lot 050-779, Model # 1523215.

General and Plastic Surgery Devices

Unclassified

No

The product is distributed directly to the firm''s sales representatives and direct accounts.

Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.

301322, 301323, 301359, 301323A, 301393 and 301360

General and Plastic Surgery Devices

Unclassified

No

Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom

D-Stat Dry Hemostatic Bandage, model number 3000. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Dry hemostatic bandage (D-Stat Dry) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Adhesive bandage

Lot numbers 301323A and 301393

General and Plastic Surgery Devices

Unclassified

No

The product was shipped to hospitals/medical facilities in AZ, CA, FL, GA, IL, MA, MN, MO, NY, NJ, OH, PA, TN, TX, and WI.

D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.

order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858

Hematology and Pathology Devices

Unclassified

No

Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore

Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078

301384, 301385 and 301386

General and Plastic Surgery Devices

Unclassified

No

Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom

D-Stat Hemostat Band, model number 3500. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat Radial hemostatic band (D-Stat Radial) consists of the following components: -Lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride in a nonwoven gauze; -Application device consisting of an adjustable retention strap, collar and attached gauze pad.

301404

General and Plastic Surgery Devices

Unclassified

No

Within the US to AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, RI, SC, TX, UT, VA, WI and WV. OUS to include: Italy, United Kingdom

D-Stat 2 Dry Hemostatic Bandage, model number 3010. Sterile, latex free single use device. Vascular Solutions, Inc. 6464 Sycamore Court, Minneapolis, MN 55369 USA. Each D-Stat 2 Dry hemostatic bandage (D-Stat 2 Dry) consists of the following components: -One (1) scored lyophilized pad consisting of thrombin, sodium carboxylmethyulcellulose and calcium chloride; -Two (2) Adhesive bandages.

Part No. 61000, Serial Numbers 1P00100 to 1P00141.

Gastroenterology-Urology Devices

Unclassified

No

US, Canada, Australia, Europe.

Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.

Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.

Physical Medicine Devices

Unclassified

No

Nationwide Distribution.

Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.

Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1.

General Hospital and Personal Use Devices

Unclassified

No

Worldwide Distribution - USA, including AL, CO, FL, GA, IN, KS, KY, MA, MO, NC, NH, NJ, NY, OH, PA, TN, and WA and the country of Canada

Hospital Information System Results Reporting Interface Versions 4.0.2.38.1, 4.0.2.39.2, 4.02.40.1, and 4.0.2.41.1. || SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760. || Manufacture Dates: || 4.0.2.38.1 06/15/07 || 4.02.39.2 06/29/07, || 4.02.40.1 07/19/07, || 4.02.41.1 08/20/07. || The Result Reporting Interface is a highly versatile interface designed to electronically convey clinical laboratory orders and results for the SCC applications to other recipient information systems.

Lot numbers: WKT252, YLT061, ZCT011 and ZGT052.

Gastroenterology-Urology Devices

Unclassified

No

Nationwide distribution: including states of: AL, AR, AZ, CA, CT, GA, KY, MN, NC, NJ, OH, TN, and TX.

Fresenius Red Blood Cell Set, Catalog Number 9007601. || The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". || Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.