The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and… — Class II medical device recall Z-1007-2015
Terminated recall by Arrow International Inc, reported 2015-01-28. The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it c
| Recall number | Z-1007-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2013-02-04 |
| Classified | 2015-01-22 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2016-10-14 |
| Countries outside the US | CA |
| Quantity | 2,480 |
| Reason classes | packaging |
| Lot numbers | RF2056545, RF2056557, RF2057719, RF2058355, RF2058357, RF2058764, RF2060414, RF2060811, RF2060829, RF2060831, RF2060836, RF2060899, RF2069798, RF2069964, RF2071317, RF2071325, RF2083836, RF2083837, RF2084162, RF2084897, RF2084898, RF2095946, RF2096027, RF2096348, RF2107409, RF2107410, RF2108324, RF2108326, RF2108329, RF2108330, RF2110441, RF2110442, RF2111259, RF2119933, RF2119935, RF2121820, RF2121821, RF2121827, RF2122497 |
| Model 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, CSD-15322-I |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1007-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.