The Recall Desk
Severity pendingFDA (Devices)·Z-2367-2026·Announced 2026-06-24

Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR

Pending LLM rewrite. Source: FDA_DEVICE Z-2367-2026.

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: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) A
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): DLX-45563-VPSB/10801902193275/33F25C0704
  • 33F25D0316
  • 33F25D0627
  • 33F25M0094
  • 33F24L0860
  • DLX-45563-VPSC/10801902193275
  • 10801902208658
  • 10801902210118/33F25B0509
  • 33F25C0340
  • 33F25D0255
  • 33F25D0628
  • 33F25E0767
  • 33F25E0901
  • 33F25F0227
  • 33F25J0448
  • 33F25K0036
  • 33F26C0104
  • 33F26C0107
  • 33F24C0257
  • ASK-04001-UCHD1/10801902193275

Distribution

Distributed nationwide across the United States.

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