Z-1285-2018Class II

Radial Artery Catheterization Kit; Model: AK-04122

Name: Z-1285-2018 Radial Artery Catheterization Kit; Model: AK-04122
Creator: Arrow International Inc
Published: 2017-10-26
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-10-26 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Radial Artery Catheterization Kit; Model: AK-04122 on 2017-10-26. FDA classified it as Class II and gives the reason as "The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1285-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-26
Posted: 2018-04-02
Terminated: 2019-12-10
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Radial Artery Catheterization Kit; Model: AK-04122
Product code: DQX Wire, Guide, Catheter
Reason for recall: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form.
Quantity in commerce: 570
Distribution: US nationwide distribution, including Puerto Rico.
Product codes and lots: Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1285-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1281-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1282-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1283-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1284-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1285-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1286-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1287-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02

Product code DQX

K810675Class IIArrow Radial Artery Catheterization SetArrow Intl., Inc. / cleared 1981-03-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)