Multi-lumen Hemodialysis Catheterization Kit
Gastroenterology, Urology · 21 CFR 876.5540
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent MDR events
45 adverse event reports on file
- ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CMJul 27, 2026MalfunctionArrow International Llc9680794-2026-00544
- ARROW HEMODIALYSIS SET: 2-LUMENJul 27, 2026MalfunctionArrow International Llc3006425876-2026-00792
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMJul 20, 2026MalfunctionArrow International Llc3006425876-2026-00783
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMJul 13, 2026MalfunctionArrow International Llc3006425876-2026-00743
- ARROW AHDC KIT: 3-L 12 FR X 20 CMJul 13, 2026MalfunctionArrow International Llc9680794-2026-00520
- ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CMJul 6, 2026MalfunctionArrow International Llc9680794-2026-00501
- ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CMJun 22, 2026MalfunctionArrow International Llc9680794-2026-00471
- ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTEJun 12, 2026MalfunctionArrow International Llc9680794-2026-00447
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMJun 8, 2026MalfunctionArrow International Llc3006425876-2026-00595
- ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETRJun 8, 2026MalfunctionArrow International Llc9680794-2026-00450
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
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.
Z-2372-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
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.
Z-2388-2026 · View FDA record ↗
Registered firms
11 firms currently registered for this product code
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Teleflex Medical Llc
Morrisville, NC, US
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc
El Paso, TX, US
Arrow International, Llc (subsidiary Of Teleflex Incorporated)
Wyomissing, PA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Sterigenics U.s., Llc
Charlotte, NC, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.