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Class 2 Device Recall PeriVac |
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| Date Initiated by Firm |
September 29, 2003 |
| Date Posted |
October 30, 2003 |
| Recall Status1 |
Terminated 3 on March 09, 2004 |
| Recall Number |
Z-0071-04 |
| Recall Event ID |
27454 |
| 510(K)Number |
K032050
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| Product Classification |
Wire, Guide, Catheter - Product Code DQX
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| 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
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| For Additional Information Contact |
Mark Chen
408-895-3626
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Manufacturer Reason
for Recall |
The product has the potential to break during withdrawal process.
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FDA Determined
Cause 2 |
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
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| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = DQX and Original Applicant = BOSTON SCIENTIFIC CORP.
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