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Recall Observatory FDA recall evidence

Device 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.

Z-1080-2015

January 05, 2015

Class II

Product summary

Firm
Arrow International Inc
Event
Event 70177
Status
Terminated
Classification
Class II
Quantity
63022
Official record key
device-enforcement:Z-1080-2015

Official wording

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

Code information: 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.

Distribution pattern: Distribution US Nationwide, Canada and Mexico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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