Device product
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
Z-1170-2020
Product summary
- Event
- Event 84726
- Status
- Terminated
- Classification
- Class II
- Quantity
- 343105 total
- Official record key
device-enforcement:Z-1170-2020
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: 71F19E2457 71F19G0988 71F19H1281 71F19K2009 71F19F1658 71F19G2371 71F19J1079
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.