Device product
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0009-2020
Product summary
- Event
- Event 83119
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,312 each
- Official record key
device-enforcement:Z-0009-2020
Official wording
Reason: Device vented gas below the stated pressure.
Code information: Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327
Distribution pattern: US nationwide distribution. AL, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TX, VA, WA and WY
Derived failure modes
-
Unknown
Device vented gas below the stated pressure.