Patient Breathing Circuit Recalled Due to Leakage at Valve
Isolated episodes of leakage at the check valve have been found
A design flaw has prompted Draeger Medical to recall 42,922 VentStar Oxylog 3000 Disposable Pediatric Patient Circuits, 1,530 of which were distributed in the U.S.
Certain isolated episodes of leakage have been found at the check valve on the circuits, which are used with the Draeger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
The circuit is enclosed in blue tubing and measures 15 millimeters in diameter. The kit also includes an expiration valve, flow sensor, measurement lines, and a double swivel elbow. It measures 190 centimeters (75 inches) and is latex free. 25 units are included in each pack.
The recalled circuit was distributed in the following states: 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.
The manufacturer has not reported whether there have been any injuries reported related to this recall, which began on August 04, 2016.
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, namely to inspect stock and dispose of affected products.
For more information, consumers may call Draeger Technical Support at (800) 543-5047 and press four at the prompt.