Z-2804-2020Class II

NextStep Retrograde Replacement Hub Set -

Name: Z-2804-2020 NextStep Retrograde Replacement Hub Set -
Creator: Arrow International Inc
Published: 2020-07-06
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2020-07-06 / Terminated / root cause: sterility

FDA source

Arrow International Inc began a recall of NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been... on 2020-07-06. FDA classified it as Class II and gives the reason as "The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2804-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-06
Posted: 2020-08-13
Terminated: 2021-11-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
Product code: NFK Kit, Repair, Catheter, Hemodialysis
Reason for recall: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
Root cause tag: sterility
FDA root cause: Incorrect or no expiration date
Action: Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.
Distribution: World wide distribution
Product codes and lots: Product Code: NRH-15192 Lot #: 13F19H0454

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2804-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2801-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13
Z-2802-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13
Z-2803-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13
Z-2804-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13

Product code NFK

K020430Class IIDiatek Connector Assembly Replacement Kit (Cark)Diatek, Inc. / cleared 2002-05-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)