RecallRadar

FDA Device recall Z-2380-2026

Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

On 2026-06-24 the FDA classified a Class I recall of Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 by Arrow International, citing 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 rep….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2380-2026
ClassificationClass I
Statusongoing
Initiated2026-04-21
Published2026-06-24
Last updated2026-09-13 11:58 UTC
CompanyArrow International
DistributionUS

Product

Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000

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.

Identifiers

code_info
REF(Material)/UDI-DI/Lot(Batch): AK-09000/30801902121722, 10801902193275, 20801902121756/33F24B0178, 33F24C0097, 33F24E…REF(Material)/UDI-DI/Lot(Batch): AK-09000/30801902121722, 10801902193275, 20801902121756/33F24B0178, 33F24C0097, 33F24E0336, 33F24F0311, 33F24G0335, 33F24K0101, 33F24L0795, 33F25E0919, 33F25G0467, 33F25G0758, 33F25H0722, 33F25J0468, 33F25L0463, 33F26A0389, 33F24A0368

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2380-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.