Class I — Draeger Medical, Inc.
| Recalling firm | Draeger Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Isolated episodes of leakage at the check valve were found |
| Product | Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators. |
| Quantity | 42,922 units worldwide (US distribution 1,530) |
| Distribution | US Nationwide Distribution including states of: 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. |
| Initiated | 2016-05-31 |
| Classified | 2016-08-04 |
| Terminated | 2018-03-14 |
| Recall number | Z-2215-2016 |
| 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 — Draeger Medical, Inc. (Z-2215-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74469/
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