ENFORCEMENT REPORT FOR FEBRUARY 2

ENFORCEMENT REPORT FOR FEBRUARY 2 - ENFORCEMENT REPORT FOR...

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Unformatted text preview: ENFORCEMENT REPORT FOR FEBRUARY 2, 2011 RECALLS AND FIELD CORRECTIONS: DEVICES CLASS I ___________________________________ PRODUCT Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO. Intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. Can also provide access to a native or synthetic graft used for hemodialysis. Recall # Z- 0941-2011 CODE Lot Number: H179575 RECALLING FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT, by e-mail, telephone and/or fax, dated December 17, 2010. Firm initiated recall is ongoing. REASON Introducer tips may detach and embolize during use, or the tip material may elicit a thrombogenic response. VOLUME OF PRODUCT IN COMMERCE 378 units DISTRIBUTION AL, AR, CA, FL, GA, IL, MD, MI, MO, MS, ND, PA, SC, TN, and UT ___________________________________ PRODUCT Percutaneous Insertion Tray for use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845. Recall # Z- 0969-2011 CODE Lot Numbers: KF0118523 MF8092597 MF8103402 MF8114055 MF9014548 MF9046091 MF9056823 MF9057130 MF9078053 MF9088776 MF9099410 MF9109907 RECALLING FIRM/MANUFACTURER Recalling Firm: Arrow International, Inc., Division of Teleflex Medical Inc., Everett, MA, by letter on December 21, 2010. Manufacturer: Arrow Internacional de Chihuahua S.A. de C.V., Chihuahua, Mexico. Firm initiated recall is ongoing. REASON SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury. VOLUME OF PRODUCT IN COMMERCE 33,662 units DISTRIBUTION Nationwide, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia. Madrid, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Columbia, Ecuador, India, Indonesia, Japan, Korea Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela RECALLS AND FIELD CORRECTIONS: DEVICES CLASS II ___________________________________ PRODUCT 1) RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20. The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Recall # Z- 0337-2011; 2) RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20. The RX Acculink Carotid Stent System, used 2) RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20....
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This note was uploaded on 07/10/2011 for the course ECON 101 taught by Professor Tuner during the Spring '11 term at Solano Community College.

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ENFORCEMENT REPORT FOR FEBRUARY 2 - ENFORCEMENT REPORT FOR...

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