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.
FDA Recall Z-1080-2015 · Posted 2015-02-10
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeCAZ
Date Initiated2015-01-05
Date Terminated2018-07-17
Product Quantity63022
Reason for Recall
The product labeling does not specify the 5 year shelf life of the product.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Distribution US Nationwide, Canada and Mexico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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