System distributed between September 28, 2018 – December 5, 2018.

Single-Chamber Washer/Disinfectors

ORT 353C, ORT 353D and ORT 01G Orthopaedic Extensions distributed from January 20, 2016 through April 26, 2018.

Orthopaedic Extensions

Model Number: 00711175 Affected Lot Numbers: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, 1423938 Manufactured April – June 2014

Grasping device

Surgical equipment/ Anaesthesia

General equipment for medical treatment

General equipment for medical treatment - cleaning / disinfection / sterilisation

General equipment for medical treatment - cleaning / disinfection / sterilisation

General equipment for medical treatment - cleaning / disinfection / sterilisation

General equipment for medical treatment - cleaning / disinfection / sterilisation

Optics / Precision engineering - endoscopes

Catalog Number: 711140 Model Number: 711140 Batch Number: 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, 1500443

Medical devices for single use

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

Batch Number: 281551717

Medical devices for single use

V-PRO® 1, V-PRO® 1 Plus, and V-PRO® maX Low Temperature Sterilization Systems, Steris Corporation

US Endoscopy Talon grasping device, US Endoscopy

Disposable products

Model #MLR, V-PRO 1: S/N 033250701 through S/N 031571106; V-PRO 1 Plus: S/N 031800801 through S/N 031581115

General Hospital and Personal Use Devices

2

No

Worldwide Distribution -- USA (nationwide) including the states of: AK, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV & WY, and countries of: Australia, Bangladesh, Belgium, Belarus, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, India, Iraq, Ireland, Italy, Japan, Kuwait, Lebanon, Mexico, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Turkey, Vietnam, United Arab Emirates, and United Kingdom.

Amsco¿ V-PRO 1 and Amsco¿ V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. || The STERIS Amsco¿ V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices sensitive to heat and moisture.

Model # P6500, S/N: 400001 through 405005

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and the country of Bahrain.

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. || Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

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 #: 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 #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038,

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.

Verify¿ SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. || Verify¿ SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250¿F 30 minute Gravity Cycle).

Model #'s: LCC003, LCC005, LCC014 & LCC310.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.

Verify¿ SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. || Verify¿ SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275¿F 3 minute Prevacuum Cycle).

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.