Product was released for distribution to 38 consignees in US nationwide. International distribution includes EU and Canada. It did not involve Defense Supply Center, VA or other Federal Government sales/distribution centers.
Product Description
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, || Catalog/Model Numbers: 8200010, 8200TWA0
Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REPUBLIC, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, ITALY, NETHERLANDS, RUSSIAN FEDERATION, SOUTH KOREA, SPAIN, SWEDEN, and UKRAINE.
Product Description
Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. || Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. || Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. || Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. || The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.
USA (nationwide) and the countries of Canada, Columbia, Viet Nam, Germany, France, Great Britain, Italy, Jordan, Kuwait, Netherlands Pakistan, Portugal, S. Arabia, Slovakia, Spain, Sweden and Tunisia.
Product Description
Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. || The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, El Salvador, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, Ukraine, Vietnam, South Africa, Dutch Antilles, Sri Lanka, Libya, and Yemen
Product Description
Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. || The following products being recalled: || Imager" II Catheters C1 || 5fr 65cm || M0064003001 M0064003000 || 400-300 || Imager" II Catheters C2 || 5fr 65cm || M0064003011 M0064003010 || Catalog # 400-301 || Imager" II Catheters || Straight 5fr 65cm || M0064003021 M0064003020 || Catalog #400-302 || Imager" II Catheters || Bern 5fr 65cm || M0064003031 M0064003030 || Catalog #400-303 || Imager" II Catheters || JB1 5fr 65cm || M0064003041 M0064003040 || Catalog #400-304 || Imager" II Catheters || Straight 5fr 100cm || M0064004021 M0064004020 || Catalog #400-402 || Imager" II Catheters || Bern 5fr 100cm || M0064004031 M0064004030 || Catalog #400-403 || Imager" II Catheters || JB1 5fr 100cm || M0064004041 M0064004040 || Catalog #400-404 || Imager" II Catheters || Bern 5fr 40cm || M0064005031 M0064005030 || Catalog #400-503 || The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.
Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, El Salvador, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, Ukraine, Vietnam, South Africa, Dutch Antilles, Sri Lanka, Libya, and Yemen
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Product Description
Boston Scientific Profile Single-Use Pediatric Snare 11mm || UPN Outer Box M00562531 || Inner Pouch: M00562530 , || The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop