Recall Z-2215-2016 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
| Date | Aug 4, 2016 (initiated May 31, 2016) |
| Status | Terminated |
| Reason | Isolated episodes of leakage at the check valve were found |
| Root cause | Device Design |
| Action | Drager sent an Urgent Medical Device Recall letter dated May 31, 2016 and Customer Reply and Order Card to all customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to inspect stock and dispose of affected products. For questions regarding this letter call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger device/accessory contact DrgerService Technical Support at 1-800- 543-5047 (press 4 at the prompt). |
| Quantity | 42,922 units worldwide (US distribution 1,530) |
| Distribution | US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062267 | OXYLOG 3000 Drager Medical B.V., Oct 31, 2006 |