FDAFDA · Food and drugs·Recall number Z-1478-2015
6" Trifurcated set with Bionectors, Product Code: BN-944 Accessory device used to administer medical fluids
Published April 29, 2015 · Recall initiated: January 15, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for leaking caused by insufficient bond between needleless device and female luer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Churchill Medical Systems, Inc.
- Distributor
- Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
- Lot
- 1310051 1312063
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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