BEUDAMED
    FDA Recall Terminated

    PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305

    Recall: Z-0071-04 · Initiated September 29, 2003

    Recall

    Recall Number
    Z-0071-04
    Event Number
    27454
    Firm
    Boston Scientific
    FEI Number
    3001236349
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2003
    Posted
    October 30, 2003
    Terminated
    March 9, 2004
    Address
    2710 Orchard Pkwy, San Jose, CA, 95134

    Description

    PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305

    Reason

    The product has the potential to break during withdrawal process.

    Action

    On 9/22/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.

    Distribution

    The product was distributed worldwide to hospitals and medical supply distributors, totaling 1100 consignees. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, and hospitals which received the recalled product. The product was distributed by direct sale to the following government/military accounts: 1) Brooke Army Med Ctr., 3851 Roger Brook Dr., Fort Sam Houston, TX 78234, 210-916-3083; 2) National Naval Med Ctr., 8901 Wisconsin Ave., Bethesda, MD 20889, 301-295-6756; 3) Naval Med Center, 34800 Bob Wilson Dr. San Diego, CA 92134, 619-532-9570; 4) VA Med Center, 4500 S Lancaster Rd., Dallas, TX 75216, 214-857-1757; 5) VA Med Center, 385 Tremont Ave., East Orange, NJ 07018, 973-676-1241; 6) VA Med Center, 50 Irving St., NW, Washington, DC 20422, 202-745-8000; 7) VA Med Center, BLDG 143 ? 1970 Roanoke Blvd. Salem, VA 24153, 540-983-1051; 8) VA Med Center, 3600 30th St., BLDG ? 10, Des Moines, IA 50310, 516-266-6062; 9) VA Med Center, Highway 6th West, Iowa City, IA 52246, 319-338-0581; 10) VA Med Center, 1601 Perdido St., New Orleans, LA 70146, 504-589-5994; 11) VA Med Center, 2002 Holconbe Blvd, Houston, TX 77030, 713-791-1414; 12) VA Med Center, 1055 Clermont St., Denver, CO 80220, 303-393-2850; 13) VA Med Center, 500 Foothill Dr. Salt Lake City, UT 84148, 801-584-1243; 14) VA Med Center, 1501 San Pedro SE, albuquerque, NW 87108, 505-256-2727; 15) VA Med Center, 3350 La Jolla Village Dr. San Diego, CA 92161, 858-552-8585; 16) VA Med Center, 3801Miranda Ave., Palo Alto, CA 94304, 650-447-2560; 17) VA Med Center, 1660 S Columbian Way, Seattle, WA 98108, 206-764-2008 18) VA Med Center, 130 W Kingsbridge Rd., Bronx, NY 10468, 718-584-9000; 19) VA Med Center, 5901 E 7th St., Bld 149, Long Beach, CA 90822, 310-547-8220; 20) VA Med Center, 10535 Hospital Way, Mather, CA 95655, 916-643-5844; 21)VA Westside Medical Center, 350 E Erie St., Chico, IL 60611, 312-943-6600

    Quantity

    11835 units