Device product
FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
Z-1203-2020
Product summary
- Event
- Event 84726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 343,105 total
- Official record key
device-enforcement:Z-1203-2020
Official wording
Reason: 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.
Code information: Lots: 71F19A1623 71F19B0507 14F19D0467 71F19G0728 71F19J1893 14F19L0127 71F19A2295 14F19B0224 71F19E1270 71F19G0974 71F19K0694 71F19A2972 14F19D0011 71F19E1868 71F19J0168 71F19K0899 71F19B0343 71F19D2947 71F19F0330 14F19J0132 71F19K2112
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.