Medical devices, 2012: every recall, from FDA

Medical device recall TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY… During an FDA inspection, the firm was notified of Quality System deficiencies, which included lack of procedures for design control and customized… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement Report23 statesnamed in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, New Hampshire, New Jersey, New Mexico, Ohio, Pennsylvania, Rhode Island, Texas and Virginia

Medical device recall AUTOMIX High Speed Compounder System, product 2M8077 After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX… FDA Class I, its most serious class Class IFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall AUTOMIX Plus High Speed Compounder System, product 2M8075 After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX… FDA Class I, its most serious class Class IFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall AUTOMIX 3+3 Compounder System, product 2M8286 After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX… FDA Class I, its most serious class Class IFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287 After fluid ingress into the keypad of the AUTOMIX Compounder’s (AUTOMIX) control module, the AUTOMIX may generate an incorrect device response to an AUTOMIX… FDA Class I, its most serious class Class IFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 15, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13 On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall djo surgical Screw 6.5 mm, Sz 25mm, low profile One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Idaho, Oklahoma, Pennsylvania, Texas and Utah named

Medical device recall CrossFT Punch, Product Number PFT-45M ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado and Pennsylvania named

Medical device recall Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900 Defective camera: There is a possibility that the connection of the wires to the connector may become loose, causing image distortion or loss. Class IIIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 15, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Florida, Michigan, Mississippi and New Hampshire named

Medical device recall Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform… On 07/09/2012, Apheresis Technologies, Inc. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure,… Battery may become hot and leak Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and New York and Ohio named

Medical device recall PopLok Punch labeled in part: “PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diameter is 4.5mm when it should have been 3.5mm. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006 Ten units of Model EMV+ Devices were shipped out in error before the verification and validation was completed for a new integrated circuit (IC) on the CPU PCB. Class IIIFDA’s classAug 15, 2012in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedAug 15, 2012ClassClass IIIStatusTerminatedWhereIllinois

Medical device recall Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0 A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and New York and Ohio named

Medical device recall 3mL 9NC Coagulation Sodium Citrate 3.2% Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall LUXOR RETRACTOR BASE Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Michigan, Minnesota, North Carolina, New York and Virginia named

Medical device recall I-STAT PT/INR cartridge Abbott Point of Care Inc The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET… Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for… During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within… Class IIIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 15, 2012ClassClass IIIStatusTerminatedWhereNo state named

Medical device recall The finger cots are made out of natural rubber The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Illinois, Indiana, Michigan, New Hampshire, Nevada, Tennessee, Texas and West Virginia named

Medical device recall Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2 Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The ABL software version 6.12 for the ABL800 analyzer A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall The ABL software version 6.12 for the ABL800 and ABL700 analyzer A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall ABL90 FLEX software version 2.7 MR3 A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with… Distal part of the anchor may break on insertion into bone during surgery Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Distal part of the anchor may break on insertion into bone during surgery Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-blue, COBRAIDblack), sterile Distal part of the anchor may break on insertion into bone during surgery Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Distal part of the anchor may break on insertion into bone during surgery Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall i-Stat cTnl cartridges Abbott Point of Care Inc The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereArizona and Colorado

Medical device recall i-Stat BNP cartridges Abbott Point of Care Inc The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereArizona and Colorado

Medical device recall i-Stat CK-MP cartridges Abbott Point of Care Inc The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereArizona and Colorado

Medical device recall EasyLink(TM) Informatics System There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the EasyLink… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens syngo(R) Lab Data Manager The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Missouri, Mississippi, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania and Texas named

Medical device recall Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC Siemens has received complaints of customers experiencing slopes >1.05 when calibrating Flex(R) reagent cartridge lot 12095AD. Class IIIFDA’s classAug 15, 2012in FDA’s Enforcement Report39 statesnamed in where it went PublishedAug 15, 2012ClassClass IIIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia

Medical device recall Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument,… Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, North Carolina, New Mexico, New York, Ohio, Tennessee and Texas named

Medical device recall System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal… Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal… Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medstream 81” Devices leaking at the Y-site Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled. Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Kansas, Missouri and North Carolina named

Medical device recall Kimberly Clark Patient Warming System A defect of the “fuse holder” can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, Mississippi, Nebraska, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named

Medical device recall Dimension(R) Reagent Management System (RMS) - Power Cord Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can… Class IIFDA’s classAug 15, 2012in FDA’s Enforcement Report51 statesnamed in where it went PublishedAug 15, 2012ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended… Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Class IIFDA’s classAug 8, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 8, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical devices, 2012

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