The Recall Desk
Severity pendingFDA (Devices)·Z-2375-2026·Announced 2026-06-24

Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB

Pending LLM rewrite. Source: FDA_DEVICE Z-2375-2026.

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: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB+/ASK-45703-PNHS2; PI CVC KIT: 4L 8.5 FR X 20 CM AGB+/ASK-45854-PNHS2
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 (3)

  • REF(Material)/UDI-DI/Lot(Batch): ASK-42703-PNHS2/10801902193275/33F25J0107
  • ASK-45703-PNHS2/10801902193275/33F25B0593
  • ASK-45854-PNHS2/10801902193275/33F24H0128

Distribution

Distributed nationwide across the United States.

Related recalls

Same category