RecallRadar

FDA Device recall Z-1201-2020

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

On 2020-02-19 the FDA classified a Class II recall of FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-B 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-1201-2020
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 Set, Product Code JC-05400-B

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: 71F19A0552 71F19C0531 71F19D1772 71F19F0481 71F19G2970 71F19K1979 71F19A1876 71F19C1329 71F19D2237 71F19…Lots: 71F19A0552 71F19C0531 71F19D1772 71F19F0481 71F19G2970 71F19K1979 71F19A1876 71F19C1329 71F19D2237 71F19F0794 71F19H1056 71F19K2381 71F19A2686 71F19C2027 71F19D2580 71F19F1426 71F19H1236 71F19K2382 71F19A2926 71F19C2239 71F19E0587 71F19F2006 71F19H1300 71F19L0281 71F19B0499 71F19C2723 71F19E0689 71F19G0494 71F19H2034 71F19L0502 71F19B1222 71F19C2866 71F19E1636 71F19G1028 71F19J0768 71F19L0653 71F19B2079 71F19D0056 71F19E2838 71F19G1720 71F19J1251 71F19B2664 71F19D0839 71F19E3183 71F19G2237 71F19J2203 71F19B2849 71F19D1511 71F19F0256 71F19G2837 71F19J2204

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-1201-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.