Device product
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCSHO
Z-1190-2020
Product summary
- Event
- Event 84726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 343,105 total
- Official record key
device-enforcement:Z-1190-2020
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: 71F19C0983 71F19D0315 71F19E1828 71F19H1445 71F19J1822 71F19K1828
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.