Recall Z-1071-2019 ยท DRS Transducer, Blood-Pressure, Extravascular
ICU Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
| Date | Nov 27, 2018 |
| Status | Terminated |
| Reason | Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path. |
| Root cause | Process design |
| Action | On 11/27/18, Urgent Medical Device Recall notices were sent via traceable mailing to customers informing them to discontinue use and distribution of the affected product. In addition, customers were asked to quarantine and return affected product, and to complete and return response forms. Customers were instructed to inform all potential users of the product within their organization, and if the product had been further distributed, to immediately notify these additional customers. Customers with additional questions were encouraged to call: Global Complaint Management @ 1-844-654-7780 (Pr |
| Quantity | 280 |
| Distribution | U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052828 | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) Hospira, Inc., Feb 17, 2006 |