Arrow International Inc: Medical Device Recall in 2015 - (Recall #: Z-1007-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.

Product Classification:

Class II

Date Initiated: February 4, 2013

Date Posted: January 28, 2015

Recall Number: Z-1007-2015

Event ID: 69938

Reason for Recall:

The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

Status: Terminated

Product Quantity: 2,480

Code Information:

Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829, RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837, RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355, RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821, RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330, RF2121820, RF2057719, RF2056545, RF2111259, RF2096348.

Distribution Pattern:

Worldwide Distribution -- US and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated