FDAClass IIFebruary 19, 2020

FlexTip Plus Epidural Catheterization Kit recall

FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220

Why was FlexTip Plus 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: 13F18J0481 13F19D0441 13F19E0237 13F19K0136 13F19L0363 13F19A0671 13F19D0671 13F19G0613 13F19K0544

Product
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
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