FDAFDA · Food and drugs·Recall number Z-1173-2020
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
Published February 19, 2020 · Recall initiated: January 15, 2020
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
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
- Lot
- Lots: 71F19B0681 71F19C0035 71F19D2827 71F19F2028 71F19H1633 71F19K1574
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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