FDA Device recall Z-1007-2015
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access,…
- FDA Device
- Class II
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class II recall of The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access,… by Arrow International, citing 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 rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1007-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-04 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
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.
Reason
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.
Identifiers
| code_info | Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829, RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1007-2015%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.