Z-2741-2016Class II

Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial...

Name: Z-2741-2016 Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial...
Creator: Arrow International Inc
Published: 2016-08-08
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-08-08 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help... on 2016-08-08. FDA classified it as Class II and gives the reason as "Shipping carton labeling error". 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-2741-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-08
Posted: 2016-09-07
Terminated: 2017-08-22
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Shipping carton labeling error.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. Customers with questions were instructed to call 1-866-246-6990.
Quantity in commerce: 690 kits
Distribution: Nationwide Distribution to OH, IN, TN, NC, and KY.
Product codes and lots: Device Listing # D025180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2741-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2740-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07
Z-2741-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07

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)