Draeger, Inc.: VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Draeger, Inc.
- Product
- VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
- Reason / hazard
- Potential cracks in the hose, which could lead to leakage or the hose falling off.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution including in the states of IN, AK, AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VT, WA, WI, WV, WY, MS, SC, UT, VA, AR, and territories AS and PR. The countries of Canada, Germany, United Kingdom, Spain, Italy, Ireland, Poland, Australia, Switzerland, Netherlands, Portugal, France, Austria, Hong Kong, Malaysia, Costa Rica, Andorra, Belgium, Sweden, Cyprus, Greece, Latvia, Romania, Albania, Moldavia, Kazakhstan, Croatia, Libya, Mauritius, Honduras, Suriname, Uruguay, Syria, Israel, Kuwait, Bahrain, Qatar, Utd.Arab.Emir., Oman, Denmark, Norway, New Zealand, Brunei Darussalam, Singapore, China, India, Japan.
- Recall initiated
- 2026-09-03
- Code info
- Part Number MP00310. UDIDI: 04048675422358. All lot numbers.
- Product quantity
- 1,063,643 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Telford
- State
- PA
- Country
- United States
- Event id
- 99787
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