FDAClass IIFebruary 19, 2020

FlexTip Plus Combined Spinal Epidural Catheterization recall

FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH

Why was FlexTip Plus Combined Spinal Epidural Catheterization 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: 13F18L0892 13F19C0478 13F19E0433 13F19K0051 13F19B0588 13F19D0327 13F19H0209 13F19L0079

Product
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-WH
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