medical_device

Model #'s: Cmax110, Cmax 220

General and Plastic Surgery Devices

1

No

Worldwide Distribution: USA in the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV, and in the countries of Australia, Canada, China, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan.

Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in Montgomery, AL

Model Catalog: (Lot serial: C436306020); Model Catalog: (Lot serial: C436306018); Model Catalog: (Lot serial: C431706002); Model Catalog: (Lot serial: C434506008); Model Catalog: (Lot serial: C430506054)

CMAX SURGICAL TABLES

Model Catalog: CMAX 110 (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 11053 TO 15360); Model Catalog: CMAX 220 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 110 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832050 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832051 (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: P150832JEJ (Lot serial: S/N: C410906119 TO C427008040); Model Catalog: CMAX 220 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832050 (Lot serial: S/N: 11053 TO 15360); Model Catalog: P150832JEJ (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832051 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: P150832050 (Lot serial: S/N: 0428208115 TO 0417309157); Model Catalog: CMAX 110 (Lot serial: S/N: 0428208115 TO 0417309157)

CMAX SURGICAL TABLE

Synergy Health:

Synergy Health: DETEX

Catalog Number: 28949 Model Number: 30 x 30cm, 18ply, stitched and taped, 5 Tied, Double Wrapped. Batch Number: 289493515, 289493415, 289490116, 289490316, 289490416, 289490616, 289491516, 289491616, 289491716, 289491816, 289491916, 289492016

Medical devices for single use

DETEX X-ray Detectable Swabs

Detex X-Ray Detectable Tied 5 Gauze Swab BP

B420702032 to 0402110097

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico and the following countries: American Samoa, Argentina, Australia, Bahrain, Bangladesh, Bermuda, Brazil, Canada, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Germany, Greece, Guam, Hong Kong, India, Indonesia, Israel, Italy, Japa, Jordan, Kazakhstan, Korea, Kuwait, Lebanon , Libya , Malaysia , Mexico, Morocco, New Zealand, Panama, Peru, Philippines , Poland, Portugal, Qatar, Russia, Saudi Arabia , Singapore, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Trinidad and Tobago, Turkey & United Kingdom.

A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. || Product Usage: || Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable components and accessories intended for use during diagnostic examinations or surgical procedures to support and position a patient.

Serial Numbers 0428102135-0428307020

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.

Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

Serial Numbers 0408504214-0417907007

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.

Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

Model Number: LB61

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.

Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 || The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting

Serial Numbers 0436005042-0430207104

General and Plastic Surgery Devices

2

No

Worldwide Distribution -- United States, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates.

Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. || Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.

M/N: 00711117; Lot #: 1505956

Gastroenterology-Urology Devices

2

No

US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.

Histolock Resection Device, US Endoscopy. || An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.

2

No

Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.

Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 || The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.

Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.

Endoscopic retrieval device. || The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom.

Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. || Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices.

Model #: 1802983

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) including states of: L, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI and WY; and countries of: Australia, Canada, Hong Kong and South Korea.

Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, || The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles found in healthcare facilities.

Model # 0071151; Lot #s: 1613898, Exp. Date October 5, 2019; Lot # 1616337, Exp. Date October 7, 2019; Lot # 1616733, Exp. Date October 7, 2019; Lot # 1616734, Exp. Date October 20, 2019 & Lot # 1616735, Exp. Date October 28, 2019.

General and Plastic Surgery Devices

2

No

US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.

Roth Net Polyp Retrieval

Model #: 4085, 5085 & 5085SRT Serial Numbers: 0400710041, 0400710042, 0400710043, 0400710044, 0401510077, 0401510080, 0401510081, 0401510082, 0401510086, 0401510087, 0401510088, 0401510089, 0401510090, 0401510092, 0401910133, 0402010001, 0402010002, 0402010003, 0403210095, 0403210096, 0403210096, 0403210097, 0403210098, 0403610046, 0403610047, 0403610048, 0403610049, 0403610050, 0403610053, 0403610054, 0403610055, 0403610057, 0403610061, 0403610062, 0403610063, 0404610061, 0404610062, 0404610063, 0404610063, 0404610064, 0404610064, 0404610065, 0404610065, 0404610070, 0404610070, 0404610071, 0404610071, 0404610072, 0404610072, 0405410037, 0405410038, 0405410039, 0432709078, 0432709079, 0432709079, 0432709080, 0432709081, 0432709082, 0432709083, 0432709083, 0432709084, 0432709084, 0433609001, 0433609001, 0433609002, 0433609002, 0433609005, 0433609005, 0433609062, 0434309100, 0434309101, 0434309103, 0434809001, 0434809003, 0434809004, 0434809005, 0434809006, 0434809007, 0434809007, 0434809008, 0434809008, 0434809012, 0434809013, 0434809014, 0434809014, 0434809015, 0434809015, 0434809016, 0434809016, 0434809017, 0434809017, 0434809018, 0434809018, 0434809019, 0434809019, 0436309084, 0436309085, 0436509122, 0436509123, 0436509124 & 0436509124.

General and Plastic Surgery Devices

1

No

Worldwide distribution: USA, Australia, India, Korea & New Zealand

STERIS 4085, 5085 & 5085SRT Surgical Tables

All codes manufactured from 5/5/2010 through 3/8/2011, are subject to recall/correction.

General Hospital and Personal Use Devices

2

No

Nationwide distribution: USA including states of :CA, DE, FL, GA, IA, ID, IL, KS, MA, MO, MT, NE, NJ, NM, NY, OH, OR, SD, TX, VA, WA, WI, and WV.

STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System || The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.

MED. Serial Numbers: 400000 through 405499 are subject to correction.

General Hospital and Personal Use Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: Bahrain, Hong Kong, Japan and South Korea.

STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. || The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.

Gastroenterology-Urology Devices

2

No

Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.

Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.

Product code: 00711560; Lot #'s: 79687, 79688, 79689, 79690, 79691, 79692, 79693, 79694, 79695, 79696 80165, 80166, 80709, 80710, 80711, 80712, 80713, 80714, 80715, 80716, 80717, 80718, 80719. 80720, 80721, 80722, 80723, 81245, 81246, 81247, 81248, 81249, 81250, 81251, 81252, 81253, 81254, 81255, 81256, 81257, 81258, 81259, 81982, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81991, 82567, 82568, 82569, 82570, 82938, 82939, 82940, 82941, 82942, 82943, 82944, 82945, 82946, 82947, 82948, 82949, 82950, 82951, 82953, 82954, 82955, 82956, 84615, 84616, 84617, 84618, 84619, 84620, 84979, 84981, 85557, 86026, 86028, 86434, 86435 & 86436.

Gastroenterology-Urology Devices

2

No

USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV.

Torrent" irrigation tubing. || Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.