FDAFDA · Food and drugs·Recall number Z-1996-2014
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
Published July 16, 2014 · Recall initiated: March 28, 2014
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
Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RGI Medical Manufacturing, Inc.
- Distributor
- US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.
- Lot
- Lot numbers 102131 and 110531.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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