Device product
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP
Z-1215-2020
Product summary
- Event
- Event 84726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 343,105 total
- Official record key
device-enforcement:Z-1215-2020
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: 71F19B0757 71F19D1493 71F19E2344 71F19G2640 71F19J0575 71F19C0748 71F19E0193 71F19G1146 71F19H2120 71F19K1689
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.