Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
- Company
- Heartport Inc Route
- Recall Initiated
- October 2, 2003
- Posted
- January 9, 2004
- Terminated
- October 19, 2005
- Recall Number
- Z-0311-04
- Quantity
- 13 units
- Firm Location
- Somerville, NJ
Reason for Recall
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
Distribution
Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
Lot / Code Info
Lot number 020374
Root Cause
Other
Action Taken
Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.