BEUDAMED
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    SKINTACT ECG TAB ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK, VANCOMYCIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FLEXICAST

    FDA 510(k)
    FDA Class 2 ·Dental

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 2, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·April 16, 2008

    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013 -- Lot # 030309-02 and 030509-05 Product Usage: Intended for cutting and coagulation of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Unimed Surgical Products, Inc.·September 5, 2012

    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0013M -- Lot # 042209-02 Product Usage: Intended for cutting and coagulation of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Unimed Surgical Products, Inc.·September 5, 2012

    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline Industries, Inc. 1-800-MEDLINE***Mundelein, IL 60060 USA Made in USA.***" Part # ES0012M -- Lot # 030509-07, 052909-02, 062309-02. Product Usage: Intended for cutting and coagulation of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Unimed Surgical Products, Inc.·September 5, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code KPO·November 26, 2012

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008

    PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    FDA Recall
    Terminated ·Covidien·Product code NYU·September 19, 2008