Skip to content
Recall Observatory FDA recall evidence

Device product

FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E

Z-1203-2020

January 15, 2020

Class II

Product summary

Firm
Arrow International Inc
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

    reason.no_named_rule · v1.0.0

    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.

Field note

Send feedback

We'll only use this to respond to your feedback.