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    SPRINT FIDELIS LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LWS·April 8, 2008

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·November 18, 2009

    BRACKET/PLUG ASSY

    FDA Adverse Event
    Malfunction ·LIEBEL - FLARSHEIM CO.·Product code DXT·January 7, 2009

    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code OJG·June 6, 2022

    Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJF·November 17, 2022

    Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC, e. MAIN BASIC NEURO, f. MAJOR NEURO PK-LF, g. NEURO, h. NEURO CERVICAL PACK, i. NINOR NEURO PK-LF, j. VP SHUNT PACK Model/Catalog Number: Model Numbers: a.DYNJ0397191V, b. DYKMBNDL138, c. DYNJ907374, d. DYKMBNDL40A, e. DYNJ908260, f. DYNJ21243M, g. DYNJ904818D, DYNJ905194, DYNJ904040D, DYNJ904040F, DYNJ904818C, DYNJ905753A, h. DYNJ0101287I, i. DYNJ21244N, j. DYNJ46530J

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - SPT·August 3, 2022

    Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OII·November 17, 2022

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LFJ·November 15, 2016

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LFJ·November 15, 2016

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LFJ·September 17, 2015

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LFJ·September 21, 2015

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LFJ·September 21, 2015

    KIT 11.5X19.5CM MAHURKAR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·March 28, 2012

    KIT 11.5FX19.5CM MAHURKAR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·March 28, 2012

    KIT 11.5FX13.5 CE MAHURKAR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·January 19, 2012

    KIT 28CM PERMCATH

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·January 26, 2012

    36CM PERM CATH KIT X5

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code LFJ·March 8, 2012

    11.5FX 15CM HEMO-CATH

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code LFJ·May 9, 2014

    HEMOGLIDE

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS·Product code LFJ·February 13, 2004

    SUBCLAVIAN CATHETER IJ

    FDA Adverse Event
    Injury ·MEDCOMP·Product code LFJ·February 9, 2004