Class 2 Device Recall PeriVac

• Date Initiated by Firm: September 29, 2003
• Date Posted: October 30, 2003
• Recall Status: Terminated on March 09, 2004
• Recall Number: Z-0071-04
• Recall Event ID: 27454
• 510(K)Number: K032050
• Product Classification: Wire, Guide, Catheter - Product Code DQX
• Product: PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305
• Code Information: Batch numbers: All units of this models; UPN numbers: M00443041, M00443051, M00443040, M00443050
• Recalling Firm/ Manufacturer: Boston Scientific; 2710 Orchard Pkwy; San Jose CA 95134
• For Additional Information Contact: Mark Chen; 408-895-3626
• Manufacturer Reason for Recall: The product has the potential to break during withdrawal process.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 11835 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQX