CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

FlexTip Plus Epidural Catheterization Kit, Product recalled

Arrow International is recalling FlexTip Plus Epidural Catheterization Kit, Product, distributed in 37 states. The recall was initiated on 15 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 23F19G0306 23F19H0035 23F19K0149 23F19L0411

Quantity recalled343,105 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1182-2020
FDA event ID: 84726
Recalling firm: Arrow International, Reading, PA
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2020
FDA classified: 13 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

15 Jan 2020	Recall initiated by company
13 Feb 2020	Classified by FDA	+29 days
19 Feb 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID

Where it was distributed

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.

Alaska Arkansas Arizona California Colorado Connecticut Florida Georgia Idaho Illinois Indiana Louisiana Massachusetts Maryland Michigan Minnesota Missouri Montana North Carolina Nebraska

Questions about this recall

Is FlexTip Plus Epidural Catheterization Kit, Product recalled?

Yes. Arrow International recalled FlexTip Plus Epidural Catheterization Kit, Product on 15 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1182-2020.

Why was it recalled?

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.

Which lots are affected?

Lots: 23F19G0306 23F19H0035 23F19K0149 23F19L0411

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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