Recall Z-0570-2017 ยท DRS Transducer, Blood-Pressure, Extravascular
ICU Medical, Inc.
Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 cc Control Syringe, Item No. 46300-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Re
| Date | Nov 15, 2016 (initiated Sep 27, 2016) |
| Status | Terminated |
| Reason | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. |
| Root cause | Device Design |
| Action | ICU Medical sent an Urgent Medical Device Recall Notification letter dated September 27, 2016, to all affected customers to inform them of the expanded recall of the monitoring kits with Transpac IV transducers. Customers were informed of updated communications from August 10, 2016, when ICU Medical sent a communication indicating a potential leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. Based on continued evaluation, ICU Medical is expanding the notification to now include certain other monitoring kits that contain the Transpac IV transduc |
| Quantity | 270 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061573 | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT Hospira, Inc., Sep 19, 2006 |