The Recall Desk
Severity pendingFDA (Devices)·Z-2385-2026·Announced 2026-06-24

Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI

Pending LLM rewrite. Source: FDA_DEVICE Z-2385-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

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/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10 CM/ASK-09903-PHP1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-09903-UPA; PSI KIT: 9 FR X 4
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): GU-04020/30801902118807
  • 10801902193275
  • 30801902118807
  • 30801902118807/33F24C0753
  • 33F24E0736
  • 33F24G0154
  • 33F24G0648
  • 33F24H0377
  • 33F25A0059
  • 33F25A0072
  • 33F25A0395
  • 33F25F0260
  • 33F25G0736
  • 33F25H0298
  • 33F25J0603
  • 33F26B0084
  • 33F26B0314
  • 33F26C0578
  • 33F24D0036
  • AK-09803-CDC/20801902121756

Distribution

Distributed nationwide across the United States.

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