FDAClass IIFebruary 19, 2020

FlexTip Plus Combined Spinal Epidural Catheterization recall

FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B

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: 71F19E2457 71F19G0988 71F19H1281 71F19K2009 71F19F1658 71F19G2371 71F19J1079

Product
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
Recalling firm
Arrow International Inc
Quantity
343105 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