Class I — TELEFLEX-MORRISVILLE
| Recalling firm | Teleflex |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Device vented gas below the stated pressure. |
| Product | Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators. |
| 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 |
| Initiated | 2019-06-14 |
| Classified | 2019-11-06 |
| Terminated | 2024-06-12 |
| Recall number | Z-0009-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — TELEFLEX-MORRISVILLE (Z-0009-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83119/
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