RecallRadar

FDA Device recall Z-1080-2015

ARROW Epidural Needle Component (product number AN-05501)

On 2015-02-18 the FDA classified a Class II recall of ARROW Epidural Needle Component (product number AN-05501) by Arrow International, citing the product labeling does not specify the 5 year shelf life of the product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1080-2015
ClassificationClass II
Statusterminated
Initiated2015-01-05
Published2015-02-18
Last updated2026-09-13 11:53 UTC
CompanyArrow International
DistributionUS

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.

Reason

The product labeling does not specify the 5 year shelf life of the product.

Identifiers

code_info
Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1080-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.