FDAClass IIFebruary 19, 2020

Epidural Catheterization KIT recall

EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP

Why was Epidural Catheterization KIT recalled?

There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots: 71F19B0757 71F19D1493 71F19E2344 71F19G2640 71F19J0575 71F19C0748 71F19E0193 71F19G1146 71F19H2120 71F19K1689

Product
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501-EXP
Recalling firm
Arrow International Inc
Quantity
343,105 total
Distribution
The products were distributed to the following US states: AK, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
Recall date
February 19, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls