Z-0076-2015Class II

Multi-Lumen Central Venous Catheterization Kit

Name: Z-0076-2015 Multi-Lumen Central Venous Catheterization Kit
Creator: Arrow International Inc
Published: 2014-09-18
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-09-18 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Multi-Lumen Central Venous Catheterization Kit on 2014-09-18. FDA classified it as Class II and gives the reason as "Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged...". 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-0076-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Posted: 2014-10-16
Terminated: 2014-12-02
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Multi-Lumen Central Venous Catheterization Kit
Product code: DQY Catheter, Percutaneous
Reason for recall: Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken. Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. Arrow International, Inc. is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 65
Distribution: US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
Product codes and lots: Catolog No - AK-12703 lot number RF3039028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0076-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0076-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

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)