FDA-Device2026-10-07Class IPROCESSING DEFECT
Draeger VentStar Resus Neo neonatal breathing circuit recalled for potential hose cracks and leakage
What this means
Draeger has recalled its VentStar Resus Neo neonatal breathing circuit (Part Number MP00310) due to potential cracks in the hose. These cracks could cause air leakage or allow the hose to separate during use. The recall affects all lot numbers distributed nationwide and internationally.
- Stop using the affected breathing circuit immediately if you have it
- Check your inventory for Part Number MP00310 and lot numbers
- Contact Draeger or your supplier for instructions on return or replacement
- Verify your current stock and remove affected units from circulation
The agency's original wording
Hazard
Potential cracks in the hose, which could lead to leakage or the hose falling off.
Intended for
Infants (under 12 months)
Illnesses reported
None reported
Sold states
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.
Affected count
1,063,643 units
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3252-2026Want us to check the next one for you?
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