Z-2201-2016Class II

Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device...

Name: Z-2201-2016 Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device...
Creator: Arrow International Inc
Published: 2016-06-02
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2016-06-02 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product... on 2016-06-02. FDA classified it as Class II and gives the reason as "Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2201-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-02
Posted: 2016-07-12
Terminated: 2017-08-21
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Product code: DQX Wire, Guide, Catheter
Reason for recall: Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Arrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to [email protected]. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 50 units in total
Distribution: US distribution in the states of TN and KY.
Product codes and lots: Lot/Batch Numbers: 23F14M0829, 23F14M0986

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2201-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2201-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12
Z-2202-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-12

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)