FDA-Device2020-02-19Class II
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
Arrow International Inc
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.
Sold states
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.
Affected count
343,105 total
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
EPIDURAL CATHETERIZATION KIT, Product Code ALZANO-05400-B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1173-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief