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
Product Description
PeriVac¿ brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”