Device product
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-12
Z-1199-2020
Product summary
- Event
- Event 84726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 343,105 total
- Official record key
device-enforcement:Z-1199-2020
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: 71F19A0623 71F19C1042 71F19E1144 71F19G2853 71F19K0248 71F19A2996 71F19C2596 71F19E2950 71F19H2549 71F19K2117 71F19B1149 71F19D2545 71F19G1138 71F19J1815 71F19L0436
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.