FDA-Device2020-02-19Class II
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
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
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1193-2020Don't want to check this manually?
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