Official recall record

Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH

US FDA — Medical Devices · 2026-04-21 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2026-04-21
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 10801902210217
Brand on record: ARROW INTERNATIONAL, LLC
Product category: Medical Device

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2026-04-21 · US FDA — Medical Devices
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EP
2026-04-21 · US FDA — Medical Devices
Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU
2026-04-21 · US FDA — Medical Devices
Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR 2L/ASK-

Other recalls from this brand

2026-04-21 · US FDA — Medical Devices
Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063
2026-04-21 · US FDA — Medical Devices
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-
2026-04-21 · US FDA — Medical Devices
Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP

All 42 official recall notices naming ARROW INTERNATIONAL, LLC on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.