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.
This recall has been terminated (originally issued August 4, 2016).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- May 31, 2016
- Posted
- August 4, 2016
- Terminated
- March 14, 2018
- Recall Number
- Z-2215-2016
- Quantity
- 42,922 units worldwide (US distribution 1,530)
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Isolated episodes of leakage at the check valve were found
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.
Lot / Code Info
Catalog Number: 5704964
Root Cause
Device Design
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).