Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatri
FDA device recall Z-2215-2016 · posted 2016-08-04 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Isolated episodes of leakage at the check valve were found
- Action taken
- 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).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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.
- Date initiated
- 2016-05-31
- Date posted
- 2016-08-04
- Date terminated
- 2018-03-14
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYLOG 3000 (K062267) | Drager Medical B.V. | 2006-10-31 |