Recall Z-0009-2020 ยท BZD Ventilator, Non-Continuous (Respirator)
TELEFLEX-MORRISVILLE
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
| Date | Nov 7, 2019 (initiated Jun 14, 2019) |
| Status | Terminated |
| Reason | Device vented gas below the stated pressure. |
| Root cause | Device Design |
| Action | On June 14 the firm sent communication with the following instructions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is |
| Quantity | 9,312 each |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110383 | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 A Plus Medical, Aug 1, 2011 |