Z-0009-2020 Class I Terminated
FDA device recall Z-0009-2020 was initiated by TELEFLEX-MORRISVILLE on June 14, 2019 and is designated Class I. Reason for recall: Device vented gas below the stated pressure. The recall status is terminated (terminated June 12, 2024). Affected quantity: 9,312 each.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- June 14, 2019
- Termination Date
- June 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,312 each
Product Description
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Reason for Recall
Device vented gas below the stated pressure.
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
Code Information
Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327