FDA-Device2020-02-19Class II
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-FR1
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 UR-05501-FR1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1216-2020Don't want to check this manually?
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