Z-1080-2015Class II

ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural...

Name: Z-1080-2015 ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural...
Creator: Arrow International Inc
Published: 2015-01-05
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2015-01-05 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter... on 2015-01-05. FDA classified it as Class II and gives the reason as "The product labeling does not specify the 5 year shelf life of the product". 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-1080-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-05
Posted: 2015-02-10
Terminated: 2018-07-17
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: The product labeling does not specify the 5 year shelf life of the product.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Urgent Medical Device Recall Notifications, dated January 2015, were sent to direct accounts that identified the product, problem, and actions to be taken. Customers were asked to discontinue use and return affected product.
Quantity in commerce: 63022
Distribution: Distribution US Nationwide, Canada and Mexico.
Product codes and lots: Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8070744, RF0035171, RF3026989, RF7031498, RF8083748, RF0050648, RF5084669, RF7043570, RF8096949, RF0075647, RF5094931, RF7088907, RF8123534, RF0092301, RF5106225, RF7090151, RF9015869, RF2021938, RF5118327, RF7102346, RF9030002, RF2044557, RF5120725, RF7113197, RF9071402, RF2058276, RF6081852, RF8018337, RF9098526, RF2083791, RF6092570, RF8020947, and RF9113319.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1080-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1080-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-10

Product code CAZ

K884552Class IIContinuous Epidural Anesthesia Kit W/poly CatheterArrow Intl., Inc. / cleared 1989-03-14

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)