ARROW IPN055820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902159592), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 injury.

2 FDA recall records name this device's identifier, 1 still open.

53 other recalls cover devices cleared under the same FDA submission (K071538); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 21, 2026Open, Classified

   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-2384-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Oct 27, 2022Terminated

   There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.

   Z-0352-2023 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: 'WHILE PLACING A CENTRAL LINE USING THE LINE KIT, THE PHYSICIAN EXPERIENCED AN INCIDENT WHERE, UPON BREAKING THE MASTISOL DRESSING ADHESIVE, THE VIAL CRACKED AND PIERCED THROUGH THE GLOVE, PUNCTURING THE PHYSICIAN'S SKIN'. THE PHYSICIAN DID NOT RECEIVE ANY FOLLOW-UP CARE, AND THE CONDITION OF THE PHYSICIAN IS UNKNOWN.

  Patient problems: Easy Bruising

  MAUDE report 20923939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071538. One submission often covers many models, so check the product and lot details in each record.

• Z-2376-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
• Z-1914-2026 · Mar 11, 2026 · Open, Classified
  ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-42802-PLH UDI code: (01)10801902133110(17)261231(11)251211(10)33F25L0140 REF ASK-4
• Z-2123-2026 · Jan 7, 2026 · Open, Classified
  Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
• Z-0003-2024 · Aug 10, 2023 · Open, Classified
  Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
• Z-0002-2024 · Aug 10, 2023 · Open, Classified
  Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
• Z-0351-2023 · Oct 27, 2022 · Terminated
  Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
• Z-1604-2022 · May 25, 2022 · Open, Classified
  TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
• Z-1997-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-PTJH
• Z-1994-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
• Z-1995-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product
• Z-2000-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
• Z-1996-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; P
• Z-1990-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
• Z-1991-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-45854-PSFM a
• Z-1981-2018 · Apr 11, 2018 · Terminated
  Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP

…and 38 more.