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Sources: EU EUDAMED, US FDA
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Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051 Manufactured for Lifesign LLC , Somerset, NJ 08873 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
FDA Recall
Terminated
·NERL Diagnostics Corporation·Product code JWX·January 15, 2010
Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·July 20, 2009
Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·October 7, 2008
Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media.
FDA Recall
Terminated
·NERL Diagnostics Corporation·Product code JWX·January 15, 2010
SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media.
FDA Recall
Terminated
·bioMerieux, Inc.·Product code JWX·December 21, 2011
Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
FDA Recall
Terminated
·Remel, Inc·Product code JWX·July 20, 2009
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Enforcement
Class II
·Terminated·3M Company - Health Care Business·July 15, 2015
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.
FDA Recall
Terminated
·3M Company Health Care Business 3M Center·Product code EBF·June 15, 2015
BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale
FDA Recall
Terminated
·Arjo, Inc.·Product code FRW·December 19, 2007
Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·November 5, 2008
Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·December 8, 2008
BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·November 13, 2006
Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·April 10, 2008
Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box 3527, City of Industry, CA 91744, Manufactured by BHM Medical Inc., Canada: Part number 88004051.12, Nautica Bath Lift System
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·January 23, 2007
BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·October 23, 2006
Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560) Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The equipment is intended for transferring lifts from one system track to another.
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·August 1, 2008
6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Orthopedic surgical device.
FDA Recall
Terminated
·Smith & Nephew Inc·Product code HWX·April 13, 2012
4.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code HWX·April 21, 2010
5.5MM Bone Tap, Modular; Manufactured by: Blackstone Medical, Inc. 1720 Bray Central Drive, McKinney, TX 75069. Intended to created a screw thread in a hole drilled into bone to facilitate placement of a bone screw.
FDA Recall
Terminated
·Blackstone Medical, Inc.·Product code HWX·April 21, 2010
CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWX·October 15, 2010