—#132410

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.

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K884552
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Distribution US Nationwide, Canada and Mexico.

Timeline

Recall initiated: 2015-01-05
Posted by FDA: 2015-02-10
Terminated: 2018-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132410. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.