RecallRadar

FDA Device recall Z-1172-2020

FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501

On 2020-02-19 the FDA classified a Class II recall of FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 by Arrow International, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1172-2020
ClassificationClass II
Statusterminated
Initiated2020-01-15
Published2020-02-19
Last updated2026-09-13 11:55 UTC
CompanyArrow International
DistributionAK, 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, WY

Product

FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501

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.

Identifiers

code_info
Lots: 23F19A0301 23F19F0108 23F19F0481 23F19H0079 23F19J0305 23F19L0094 23F19C0303 23F19F0297 23F19G0039 23F19…Lots: 23F19A0301 23F19F0108 23F19F0481 23F19H0079 23F19J0305 23F19L0094 23F19C0303 23F19F0297 23F19G0039 23F19H0145 23F19J0484 23F19L0209 23F19D0266 23F19F0388 23F19G0263 23F19H0386 23F19K0171 23F19M0112

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1172-2020%22

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