Medical devices, 2020: every recall, from FDA

Medical device recall Streamline TL Navigation System The Streamline Navigation System taps have experienced binding with other devices. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Michigan named

Medical device recall 5.5MM Arthrogarde Hip Access Cannula The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement Report19 statesnamed in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Georgia, Iowa, Illinois, Indiana, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Washington, Wisconsin and West Virginia

Medical device recall Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an… KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an… KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1… Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an… QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall CMEAmerica BodyGuard Wall Charger The wall charger may not properly charge the infusion pump battery. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereIllinois, Kansas and Missouri

Medical device recall Revolution Apex, Revolution CT with Apex Edition There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Illinois, Michigan, North Carolina, Nebraska, New Jersey, Pennsylvania, Texas, Virginia, Washington and Wisconsin named

Medical device recall Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is… The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Kentucky, New York, Ohio, Puerto Rico and Texas named

Medical device recall Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is… The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Indiana, Kentucky, New York, Ohio, Puerto Rico and Texas named

Medical device recall Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in… Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle. Class IIFDA’s classNov 4, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedNov 4, 2020ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Massachusetts and Rhode Island named

Medical device recall Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product… Subsequent failure of catheters in the field and failed quality testing FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Indiana, Massachusetts, Michigan, North Carolina, Pennsylvania, Tennessee and Washington named

Medical device recall Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160… Subsequent failure of catheters in the field and failed quality testing FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Indiana, Massachusetts, Michigan, North Carolina, Pennsylvania, Tennessee and Washington named

Medical device recall Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161… Subsequent failure of catheters in the field and failed quality testing FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Indiana, Massachusetts, Michigan, North Carolina, Pennsylvania, Tennessee and Washington named

Medical device recall Langston Dual Lumen Catheter The inner lumen of the Langston catheter may separate from the hub during pressure injection. FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 28, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Langston Dual Lumen Catheter. The inner lumen of the Langston catheter may separate from the hub during pressure injection. FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement Report52 statesnamed in where it went PublishedOct 28, 2020ClassClass IStatusTerminatedWhereAlaska, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Trevo XP ProVue Retriever Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 28, 2020ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia

Medical device recall Atellica IM HER-2/neu (H2n) assay, 50 Test Kit Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall VICRYL MONOFILAMENT VIOLET 4IN Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNo state named

Medical device recall AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus Product mislabeled. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the… The anterior locking detail does not meet its design specifications. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Louisiana, Michigan, Missouri, New Hampshire, New Jersey, New York, Oklahoma, Oregon and Texas named

Medical device recall Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an Olympus TV camera… The CHF-CB30S Device did not have a 510(k) clearance. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New Mexico, New York, Oregon, South Carolina, Tennessee, Washington and Wisconsin named

Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Baxter is updating the device IFU for safety communication regarding cleaning practices. FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Baxter is updating the device IFU for safety communication regarding cleaning practices. FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Spectrum IQ Infusion System with Dose IQ Safety Software Baxter is updating the device IFU for safety communication regarding cleaning practices. FDA Class I, its most serious class Class IFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 28, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich… Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin and West Virginia named

Medical device recall BD Nexiva Closed IV Catheter System Dual Port Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Illinois, Kansas, Missouri, New York, Ohio, Utah and Virginia named

Medical device recall MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce… The labels have been mistakenly printed with an IPX1 rating symbol. Class IIIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedOct 28, 2020ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner… Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kentucky, North Carolina, New Jersey, New Mexico, New York, Texas, Utah and Washington named

Medical device recall Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage:… Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kentucky, North Carolina, New Jersey, New Mexico, New York, Texas, Utah and Washington named

Medical device recall Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately… Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during… Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the… Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately… Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusTerminatedWhereNationwide

Medical device recall EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole… Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly. Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide, and California, Minnesota, Mississippi, New York, South Carolina, Tennessee and Virginia named

Medical device recall TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Number:72200777 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Number: 72200785 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Number: 72201493 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

Medical device recall ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number: 72201494 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch Class IIFDA’s classOct 28, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 28, 2020ClassClass IIStatusOngoingWhereNationwide

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