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ARROW IPN922617Recalls & reported problems

Teleflex Incorporated · Epidural Anesthesia Kit · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

10 other recalls cover devices cleared under the same FDA submission (K801912); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 21, 2026Open, Classified

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

    Z-2371-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K801912. One submission often covers many models, so check the product and lot details in each record.

  • Z-2364-2026 · Apr 21, 2026 · Open, Classified
    Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
  • Z-2803-2020 · Jul 6, 2020 · Terminated
    Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
  • Z-1175-2020 · Jan 15, 2020 · Terminated
    TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
  • Z-1248-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT AM-05500
  • Z-1251-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
  • Z-1247-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT JH-05500
  • Z-1249-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT CK-02220
  • Z-1245-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT AK-05000
  • Z-1246-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT YC-02220
  • Z-2012-2018 · Apr 11, 2018 · Terminated
    TheraCath(R) Epidural Catheter; Product Code: EC-05000

Other Anesthesia conduction kit devices

All Anesthesia conduction kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.