Catheter, Subclavian
Gastroenterology, Urology · 21 CFR 876.5540
Recent MDR events
2,170 adverse event reports on file
- ARROW VASCULAR UNKNOWNJun 25, 2026MalfunctionArrow International Llc3006425876-2026-00769
- SOFT CELL PC-2 DIALYSIS CATHETER KIT, 12.5FMar 9, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-01438
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 27, 2026MalfunctionArrow International Llc3006425876-2026-00242
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 25, 2026MalfunctionArrow International Llc3006425876-2026-00227
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 23, 2026MalfunctionArrow International Llc3006425876-2026-00195
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 20, 2026MalfunctionArrow International Llc3006425876-2026-00206
- HEMOGLYDE VASCATHFeb 19, 2026InjuryBard Access Systems, Inc.MW5184111
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 17, 2026MalfunctionArrow International Llc3006425876-2026-00207
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 12, 2026MalfunctionArrow International Llc3006425876-2026-00177
- ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CMFeb 12, 2026MalfunctionArrow International Llc3006425876-2026-00178
Event type breakdown
Recalls
6 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-2381-2026 · View FDA record ↗ - Medical Components, Inc dba MedCompTerminatedFeb 10, 2015
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH),
Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported.
Z-1083-2015 · View FDA record ↗ - Medical Components, Inc dba MedCompTerminatedUnknown
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-1149-2019 · View FDA record ↗ - Medical Components, Inc dba MedCompTerminatedUnknown
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-2215-2019 · View FDA record ↗ - Medical Components, Inc dba MedCompTerminatedUnknown
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-2216-2019 · View FDA record ↗ - Medical Components, Inc dba MedCompTerminatedUnknown
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Z-2217-2019 · View FDA record ↗
Registered firms
42 firms currently registered for this product code
Mozarc Medical Us Llc
Mansfield, MA, US
Sterigenics U.s., Llc
Santa Teresa, NM, US
Medical Components Inc
HARLEYSVILLE, PA, US
Isomedix Operations, Inc.
Temecula, CA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Medron, Llc
SALT LAKE CITY, UT, US
Teleflex Medical Llc
Morrisville, NC, US
Bard Access Systems, Inc.
Salt Lake City, UT, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Arrow International C.r. A.s.
ZDAR NAD SAZAVOU Vysocina, CZ
Covidien Llc
MANSFIELD, MA, US
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Paragon Medical - Mansfield, Bridgemedica
Mansfield, MA, US
510(k) clearances
65 clearances for this product code
- Medsurg Industries, Inc.Aug 19, 1994
K920780 · MEDSURG INSERTION TRAY
- Akcess Medical Products, Inc.Aug 2, 1994
K925819 · AKCESS0CATH KIT
- Akcess Medical Products, Inc.Apr 5, 1994
K925818 · AKCESS-CATH
- Cook, Inc.Mar 24, 1994
K913468 · ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
- Akcess Medical Products, Inc.Jan 14, 1994
K931120 · COAXIAL ACUTE CATHETER
- Akcess Medical Products, Inc.Jan 14, 1994
K920634 · SPLITTABLE SHEATH INTRODUCER SET
- Vas-Cath, Inc.Jul 1, 1993
K914162 · VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS
- Medical Components, Inc.Feb 2, 1993
K915423 · HEMO-CATH SILICONE ACCESS CATHETER