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Sources: EU EUDAMED, US FDA
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The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy.
FDA Recall
Terminated
·Cenorin·Product code LDS·June 7, 2010
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 15, 2014
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 15, 2014
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
FDA Enforcement
Class II
·Terminated·Cenorin, LLC·July 16, 2014
HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
FDA Recall
Terminated
·Cenorin, LLC·Product code LDS·January 24, 2013
NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). JD+01U3008-5C 1cc 30G x 5/16"; JD+01U3013-5C 1cc 30G x 1/2"; JD+01U3108-5C 1cc 31G x 5/16"; JD+03U3008-5C .3CC 30 g X 5/16"; JD+03U3013-5C .3CC 30 g X 1/2"; JD+03U3108-5C .3cc 31G x 516"; JD+05U3008-5C .5cc 30G x 5/16"; JD+05U3013-5C .5cc 30G x 1/2"; JD+05U3108-5C .5cc 31G x 5/16".
FDA Recall
Terminated
·Nipro Medical Corporation·Product code FMF·January 13, 2010
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
FDA Enforcement
Class II
·Terminated·Cenorin, LLC·July 4, 2018
HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
FDA Recall
Terminated
·Cenorin, LLC·Product code LDS·April 9, 2018
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code GEY·June 11, 2012
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code GFF·June 11, 2012
TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.
FDA Recall
Terminated
·TiSport, Llc·Product code IOR·July 5, 2011
HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
FDA Recall
Terminated
·Cenorin·Product code LDS·June 7, 2010
Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code MSW·October 18, 2010
HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.
FDA Recall
Terminated
·Cenorin·Product code LDS·June 7, 2010
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States."
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 2, 2016
Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
FDA Recall
Terminated
·Stryker Medical·Product code HDD·January 26, 2004
Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 10 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4469A The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.
FDA Recall
Terminated
·Product code HGD·February 7, 2012
AVE 2 Birthing Bed
FDA Recall
Terminated
·Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic·Product code HDD·January 7, 2019
Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·November 16, 2009