Recall Z-2383-2026— ARROW INTERNATIONAL, LLC

Name: FDA recall Z-2383-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Class I · Ongoing

Class I FDA medical device recall by ARROW INTERNATIONAL, LLC, initiated 2026-04-21. It names one FDA 510(k) clearance: K960479. Product: Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU. Reason: 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..

Recalling firm: ARROW INTERNATIONAL, LLC
Classification: Class I
Status: Ongoing
Initiated: 2026-04-21
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K960479 — ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETERArrow Intl., Inc.·cleared 1996-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.