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Recall Observatory FDA recall evidence

Device product

FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501

Z-1172-2020

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-1172-2020

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: 23F19A0301 23F19F0108 23F19F0481 23F19H0079 23F19J0305 23F19L0094 23F19C0303 23F19F0297 23F19G0039 23F19H0145 23F19J0484 23F19L0209 23F19D0266 23F19F0388 23F19G0263 23F19H0386 23F19K0171 23F19M0112

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.