Recall Z-2458-2015 ยท OFF Central Venous Catheter Tray
Medline Industries Inc
Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the
| Date | Aug 25, 2015 (initiated Aug 3, 2015) |
| Status | Terminated |
| Reason | The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks. |
| Root cause | Error in labeling |
| Action | Medline Industries contacted the account directly via phone on August 4, 2015, they confirmed no affected product is in their facility. The lot numbers are easily identified on the outside of each kit. Second and third follow up communications will not be sent as we have confirmed the facility does not have any affected product. For questions regarding this recall call 847-643-4129. |
| Quantity | 320 units for lot 14DB9277 & 320 units for lot 14PB2878 |
| Distribution | US including PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.