BEUDAMED
    FDA Recall Terminated

    ***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.

    Recall: Z-0071-2012 · Initiated October 25, 2010

    Recall

    Recall Number
    Z-0071-2012
    Event Number
    58302
    Firm
    Cardiocommand Inc.
    FEI Number
    1927197
    Product Code
    LPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 25, 2010
    Posted
    October 19, 2011
    Terminated
    August 28, 2012
    Address
    4920 W Cypress St, Suite 110, Tampa, FL, 33607-3837

    Description

    ***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.

    Reason

    CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG.

    Action

    On October 25, 2010, an Urgent Medical Device Recall Notice was sent by certified mail to all facilities advising them of the recall. The letter identified the affected product and reason for the recall. Users were asked to discontinue use and return the affected product to the firm. If all product was already used, then this should be indicated on the form provided. The firm will send replacement product in quantities equal to the returned product. The attached form should be completed and returned via fax. Customers were instructed to report any suspected incidents related to this issue to CardioCommand Customer Service at 1-800-231-6370. Also questions or comments should be directed to CardioCommand Customer Service.

    Distribution

    Nationwide Distribution -- GA, OR, TX, CO, KY, MT, MA, AL, CA, FL & TN.

    Quantity

    567 total