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Recall Observatory FDA recall evidence

Device product

FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS

Z-1202-2020

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-1202-2020

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: 71F19B0226 71F19B2848 71F19D0451 71F19E0081 71F19F0245 71F19J1235 71F19B0707 71F19C0406 71F19D0826 71F19E0998 71F19F0482 71F19J2164 71F19B0935 71F19C2047 71F19D1267 71F19E1253 71F19G1938 71F19K2878 71F19B1484 71F19C2433 71F19D2474 71F19E1315 71F19G2556 71F19B1832 71F19D0055 71F19D2761 71F19E2505 71F19H2404

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.