BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbers: 5103031102, 5101101101, 5102161007, 5103221007, 5104221007, 5105101008, 5109131010, 5111231011, 5114301012, 5102131101 & 5113091012. Manufactured by: Isopure Corp, Simpsonville, KY System is used to mix and distribute bicarbonate as a part of a clinical dialysis system.

    FDA Recall
    Terminated ·Isopure Corp·Product code FJP·May 19, 2011

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    FDA Recall
    Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    FDA Recall
    Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017

    FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Distributed in the USA by Diagnostica Stago, Five Century Drive, Parsippany, NJ 07054.

    FDA Recall
    Terminated ·Diagnostica Stago, Inc.·Product code DAP·December 4, 2002

    Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E

    FDA Recall
    Terminated ·Dade Behring Inc.·Product code GHH·June 21, 2005

    Coherent brand Quattro Diode Laser Systems; A Quattro FAP System; Model Numbers/Serial Numbers: TFAP0004P--TFAP00048

    FDA Recall
    Terminated ·Coherent Inc Laser Group·Product code --·November 17, 2003

    Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.

    FDA Recall
    Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code FAP·March 15, 2018

    Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005

    SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006

    FDA Recall
    Terminated ·Spes Medica Via Buccari·Product code FAP·April 8, 2021

    SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002

    FDA Recall
    Terminated ·Spes Medica Via Buccari·Product code FAP·April 8, 2021

    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

    FDA Recall
    Terminated ·EXP Pharmaceutical Services Corp·Product code FCP·February 11, 2015

    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005

    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005