The Recall Desk
Severity pendingFDA (Devices)·Z-2378-2026·Announced 2026-06-24

Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-4455

Pending LLM rewrite. Source: FDA_DEVICE Z-2378-2026.

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 PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT:
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-35563-HPKC/10801902193275/33F25D0520
  • ASK-44552-ABKB/10801902140798
  • 10801902216677/33X25K0002
  • 33S24A0529
  • ASK-45552-MHBV/10801902193275/33F25K0372
  • 33F25M0199
  • 33F26A1534
  • 33F24L0348
  • DLX-45541-HPKB/10801902193275
  • 10801902208849/33F25G0393
  • 33F25L0055
  • 33F26A1570
  • 33F24D0604
  • ASK-45052-MC/10801902216660/33S24A1242
  • CDC-44041-HPK1A/10801902193275/33F24K0430
  • CDC-44052-HPK1A/10801902193275/33F25D0241
  • CDC-44052-VPS2/10801902193275/33F25E0514
  • CDC-45063-HPK1A/10801902193275/33F25D0242
  • CDC-45541-VPS2/50801902120781
  • 10801902193275/33S24A0211

Distribution

Distributed nationwide across the United States.

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