Recall Z-0198-05 ยท DQO Catheter, Intravascular, Diagnostic
Medex Inc
MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037: Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit, MX7
| Date | Nov 16, 2004 (initiated Oct 20, 2004) |
| Status | Terminated |
| Reason | Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body. |
| Root cause | Other |
| Action | The firm sent certified letters on October 20 & 21, 2004 to all customers to whom the product was sent directly and to all distributors to whom Medex shipped the product directly in the United States. Customers in foreign countries were notified via Fed Ex. |
| Quantity | 71,132 units. |
| Distribution | The product was distributed throughout the United States to distributors and hospitals located in FL, PA, CA, NE, SC, NY, MO, NM, GA, IL, MN, NC, Washington DC, RI, CO, MS, WI, HI, TX, MI, VA, WA, NJ, KY, MA, LA, TN, AZ, MD, OR, PR, UT, TN, OH, AL, IN, NV, OK and to foreign accounts located in Mexic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K902771 | ARTERIAL BLOOD SAMPLING KIT Medex, Inc., Nov 5, 1990 |