Recall Z-1147-2013 ยท DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Transonic Systems Inc
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
| Date | Apr 18, 2013 (initiated Mar 28, 2013) |
| Status | Terminated |
| Reason | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. |
| Root cause | Component design/selection |
| Action | Transonic Systems Inc. sent an Urgent: Medical Device Recall dated March 27, 2013 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine, discontinue use and return any recalled product via FedEx. Transonic Systems Inc. has offered to reimburse the firm for the return of these recalled products by check or credit memo for the returned goods and postage. Transonic Systems Inc. has requested that if a firm has further distributed any of the above lots, that they immediately contact th |
| Quantity | 195 units total (140 units Domestic, 55 units Foreign) |
| Distribution | Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080116 | TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM Transonic Systems, Inc., Sep 8, 2008 |