Recall Z-2805-2016 ยท DRS Transducer, Blood-Pressure, Extravascular
ICU Medical, Inc.
Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: 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 compa
| Date | Sep 15, 2016 (initiated Aug 10, 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 | Process control |
| Action | An Urgent Medical Device Recall Notification letter dated 8/10/16 was sent to all their customers who purchased the Transpac IV with SafeSet reservoir kit and without SafeSet Reservoir, and with Transpac IV with marvelous valve without SafeSet reservoir. The letter informs the customers that ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The recall letter list the affected products and lot numbers. Customers are informed of the actions to be taken. Customers with questions are instructed to |
| Quantity | 420 units |
| Distribution | US 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 |