BEUDAMED
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    propper brand cal-mark(R), Micro-Hematocrit Calibrated Capillary Tubes, CALIBRATED-HEPARINIZED, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1.40-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges. Fill to the 60mm mark with blood and seal opposite end by flame or with sealing compound. If centrifuged on a direct reading centrifuge, read percent hematocrit directly from scale on the centrifuge. Otherwise, read in normal manner as a percent ratio of packed cells with 60mm of sample as 100%. Firm on label: propper manufacturing co., inc., long island city, n.y. 11101.

    FDA Recall
    Terminated ·Propper Mfg Co Inc·Product code G-IO·August 9, 2002

    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

    Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

    FDA Recall
    Terminated ·Drew Scientific Group PLC·Product code GKZ·September 20, 2006

    Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.

    FDA Recall
    Terminated ·Drew Scientific Group PLC·Product code GKZ·September 20, 2006

    W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000

    FDA Recall
    Open, Classified ·W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria·Product code KMW·January 16, 2024

    Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321.

    FDA Recall
    Terminated ·Wescor, Inc·Product code JJM·December 26, 2007

    Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321.

    FDA Recall
    Terminated ·Wescor, Inc·Product code JJM·December 26, 2007

    Oscar 2, Model 250 System

    FDA Recall
    Terminated ·Suntech Medical, Inc.·Product code DXN·April 20, 2020

    Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558

    FDA Recall
    Terminated ·ConvaTec·Product code EXB·February 14, 2008

    BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DQA·November 6, 2006

    Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code MUJ·May 3, 2011

    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.

    FDA Recall
    Open, Classified ·Ortho Kinematics, Inc·Product code LLZ·January 11, 2017

    Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.

    FDA Recall
    Terminated ·Catch Incorporated·Product code LPS·January 18, 2007

    The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·March 3, 2017

    ***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series female connector thermistor. LOT xxxxxxx 400095-0250-C 100902. www.cardiocommand.com. ***REF #250-0010***TAPSCOPE 550F CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400156-B 091101. ***REF #250-0025***TAPSCOPE 550F Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistor. FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: CARDIOCOMMAND, INC.Tampa, FL USA 33607. (800) 231-6370(813) 289-5555. www.cardiocommand.com. 400216-A 100902.

    FDA Recall
    Terminated ·Cardiocommand Inc.·Product code LPA·October 25, 2010

    ***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101. ***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.

    FDA Recall
    Terminated ·Cardiocommand Inc.·Product code LPA·October 25, 2010

    G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HKS·June 30, 2008

    Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville, Road, Reading, PA 19605 USA

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·February 17, 2005

    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.

    FDA Recall
    Terminated ·Siemens Medical Solutions, USA, Inc·Product code LLZ·March 24, 2011