Z-1965-2013Class II

Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits...

Name: Z-1965-2013 Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits...
Creator: Arrow International Inc
Published: 2013-07-31
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2013-07-31 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of... on 2013-07-31. FDA classified it as Class II and gives the reason as "Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen". 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-1965-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-08-14
Terminated: 2015-04-28
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Product code: DQY Catheter, Percutaneous
Reason for recall: Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An "Urgent Medical Device Recall Notification" letter dated July 31, 2013 was sent to direct accounts requesting immediate discontinuation of use and quarantine of all affected product on hand. Negative responses were also requested and the immediate return of product to Arrow was authorized. Questions were directed to Customer Service at 800 343-2935.
Quantity in commerce: 156
Distribution: AL, PA, CT, NC, VA, KS, RI, AZ, NJ, and IL.
Product codes and lots: Catalog # AK-17702-CDC, lot # RF2083258

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1965-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1965-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-14

Product code DQY

K862056Class II[Central Venous][multi-Lumen] Catheter W/flex TipArrow Intl., Inc. / cleared 1986-08-25

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)