BEUDAMED
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    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Enforcement
    Class II ·Terminated·Biocompatibles U.K., Ltd.·October 19, 2016

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    FDA Recall
    Terminated ·Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom·Product code NAW·September 21, 2015

    Boston Scientific BLUE MAX" 20 Balloon Dilatation Catheter, UPN M001125420 (BMQ/7-4/5.8/40, 12-542), M001125630(BMQ/9-8/5.8/40, 12-563) Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LIT·February 18, 2010

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (¿g Eq/ml) can be determined by comparison to a standard curve.

    FDA Enforcement
    Class II ·Terminated·Diagnostic Hybrids, Inc.·May 2, 2018

    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the diluted patient samples and HAGG in the controls and standards are dispensed into the C1q coated assay wells. After incubation, unbound material is removed in a washing step and a ready to use conjugate (goat anti-human Ig-HRP) is added. After a second incubation, unbound conjugate is washed away. After addition of a substrate and a short incubation interval, the quantity of CIC in the sample (g Eq/ml) can be determined by comparison to a standard curve.

    FDA Recall
    Terminated ·Diagnostic Hybrids, Inc.·Product code DAK·April 4, 2017

    LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

    FDA Recall
    Terminated ·GMP Companies/Lifesync Corporation·Product code DRG·January 10, 2007

    ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 18, 2018

    Posey Connecting Strap/Belt, Cotton, 36" (232036). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Posey Connecting Strap/Belt, Cotton, 48" (232048). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

    FDA Recall
    Terminated ·Med Tec Inc·Product code FMQ·December 11, 2014

    ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures

    FDA Recall
    Terminated ·Ethicon, Inc. Us·Product code GAQ·April 19, 2019

    Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (2794). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·September 8, 2008

    Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) (S27947). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) (2792). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

    FDA Recall
    Terminated ·J T Posey Company·Product code FMQ·April 20, 2009

    Monofilament and Multifilament Non-absorbable Steel Suture; Product Codes: 0520197-2, 29-727, 29-7270M4, 29-7281M4, E29-5553M4, E29-7270M4, E29-7272M4, E29-727A, EP4013P, EP4110N, X-2235, X29-7271M2, X-5667M8 and X-6730M5.

    FDA Recall
    Terminated ·Teleflex Medical·Product code GAQ·March 11, 2014

    DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code FMQ·February 21, 2014

    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code GBQ·June 29, 2015

    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

    FDA Recall
    Terminated ·Med Tec Inc·Product code FMQ·August 19, 2015

    Posey Connected Twice-As-Tough Cuffs

    FDA Recall
    Terminated ·TIDI PRODUCTS·Product code FMQ·April 12, 2019