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Use caution Medical device recall · FDA · Published May 8, 2020

Arrow FlexTip Plus Epidural Kit Recall: Rotatable Collar Detachment Risk

Arrow recalls FlexTip Plus Epidural Kits with NRFit Connector due to reported rotatable collar detachment causing leaks. Affected units include specific product codes and distribution lots.

🇺🇸 FDA recall #Z-2288-2020Medical deviceArrow ›
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Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

Arrow is recalling FlexTip Plus Epidural Kits with NRFit Connector after reports of the rotatable collar detaching and causing leaks. This could lead to improper medication delivery during epidural procedures. Read more at govinfonow.com/recall/65200-arrow-flextip-plus-epidural-kit-recall-rotatable-collar-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65200-arrow-flextip-plus-epidural-kit-recall-rotatable-collar-detachment-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2288-2020

Cite this page

“Arrow FlexTip Plus Epidural Kit Recall: Rotatable Collar Detachment Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65200-arrow-flextip-plus-epidural-kit-recall-rotatable-collar-detachment-risk. Based on FDA recall #Z-2288-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2288-2020%22&limit=1).

The FDA announced on May 8, 2020, that Arrow International Inc. is recalling Arrow FlexTip Plus Epidural Kits with NRFit Connectors due to a leaking filter component. The agency issued recall number Z-2288-2020 for the voluntary Class II action.

How to tell if you have it

  • Brand: Arrow
  • Product: Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system
  • Product Codes (US): OT19TAGSK, OT19TAGSKA, OT19TAPSK, OT19TCGLK
  • Product Codes (OUS): AT-05501-NRF, OT19HBPSS, UM-05400-NRF, ASK-05500-NRON, EJ-05400-NRON, OU-05500-NRON, TU-05500-NRON
  • Lots (Dist'd in US): 23F19A0260, 23F19M0224, 23F19E0120, 23F19L0014, 23F19B0184
  • Lots (Dist'd OUS): 71F19M0710, 71F18K1579, 71F18F1429, 71F18J2111, 71F20A1078, 71F20A1614, 71F19E2019, 71F19L0269, 71F19L2068, 71F19K1049, 71F19K2042, 71F19L0977, 71F19M1319, 71F20A0805, 71F20A0812, 71F20A0813, 71F19J0604, 71F19K1653, 71F19K2501, 71F19M0326, 71F20A1819, 71F20A2040, 71F20A0044, 71F19K2043, 71F19L0359
  • Distribution: US to CA, FL, MT; International to AT, AU, DE, ES, FR, JP, SG

The hazard

The FDA reported nine complaints that the rotatable collar on the filter had detached, causing a leak in the Arrow FlexTip Plus Epidural Kit with NRFit Connector.

Context

GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls of similar products include Arrow Arterial Kits and Trays (July 26, 2024), Arrow UltraFlex Intra-Aortic Balloon Catheter Kit (April 29, 2024), and ARROW QuickFlash Radial Artery Catheter (Feb. 12, 2024). Other recent recalls of similar products include Arrow FLEXTIP Plus Epidural Catheter Recall (March 11, 2026), Medline Medical Procedure Kits Recall (May 4, 2026), and Arrow recalls epidural catheter kits with possible sterility issues (April 21, 2026).

How to tell if you have this one

Check for product codes: OT19TAGSK, OT19TAGSKA, OT19TAPSK, OT19TCGLK in the US, or AT-05501-NRF, OT19HBPSS, etc. in other regions. The kit includes specific distribution lots listed in the recall notice.

  • Brand
    Arrow
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Codes

    Identify if your kit has US product codes OT19TAGSK, OT19TAGSKA, OT19TAPSK, or OT19TCGLK, or international codes listed in the recall notice.

  2. Contact Manufacturer

    Reach out to Arrow International for guidance on the recall and potential remedies.

Where it went and when

Where it was distributed

Distributed in 3 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: yesMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “US Domestic distribution to CA, FL, and MT. International distribution to AT, AU, DE, ES, FR, JP and SG.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Florida, Montana.

Recall timeline

FDA published this recall 40 days after the firm started it.

1. Firm started the recall: May 8, 202012. FDA classified it Class II: Jun 5, 202023. Published in FDA’s Enforcement Report: Jun 17, 202032020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2288-2020 (May 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2288-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA