CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
Epidural Catheterization Kit, Product recalled by Arrow International
Arrow International is recalling 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
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-1187-2020
- 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
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN
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.
AlaskaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisIndianaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNebraska
Questions about this recall
Is Epidural Catheterization Kit, Product recalled?
Yes. Arrow International recalled Epidural Catheterization Kit, Product on 15 Jan 2020. The recall is Class II and its status is Terminated. Recall number Z-1187-2020.
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: 71F19C1431 71F19H1811 71F19K1515
Where was it sold?
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.
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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