Z-1007-2015Class II

The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis...

Name: Z-1007-2015 The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis...
Creator: Arrow International Inc
Published: 2013-02-04
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2013-02-04 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers... on 2013-02-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1007-2015
Classification: Class II
Status: Terminated
Initiated: 2013-02-04
Posted: 2015-01-22
Terminated: 2016-10-14
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: MSD Catheter, Hemodialysis, Implanted
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: An Urgent Medical Device Recall Notification letter, dated February 4, 2014, was sent to direct consignees that identified the product, problem, and action to be taken. Customers were asked to discontinue use and quarantine affected inventory. The Recall Acknowledgement form should be completed and faxed back to 1-800-343-2935. A customer service representative will contact customers with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Customers are asked to contact their local sales representative or Customer Service at 1-800-343-2935 with questions.
Quantity in commerce: 2,480
Distribution: Worldwide Distribution -- US and Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1007-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1007-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-22

Product code MSD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)