The Recall Desk
HighFDA (Devices)·Z-2364-2026·Announced 2026-06-24

[pending] Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G

Pending LLM rewrite. Source: FDA_DEVICE Z-2364-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
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; STIMUCATH SFTY KIT: 20G CTH, 18Gx8CM NDL/AB-20608-KS; STIMUCATH KIT: 19G CATH, 17G x 9CM NDL/
Manufacturer
ARROW INTERNATIONAL, LLC
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF(Material)/UDI-DI/Lot(Batch): ASK-04001-SUH-S/10801902210217
  • 10801902193275/33F25C0766
  • 33F25E0112
  • 33F25G0101
  • 33F25H0058
  • 33F25H0725
  • 33F25J0862
  • 33F25M0836
  • 33F25F0160
  • ASK-04001-VM1/10801902210217
  • 10801902202106
  • 10801902193275/33F24L0599
  • 33F26A0962
  • 33F24G0280
  • AB-19604-KS/10801902210217
  • 10801902209471/33F24L0608
  • 33F25G0474
  • 33F25J0814
  • 33F25M0887
  • 33F24D0064

Distribution

Distributed nationwide across the United States.

Related recalls

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