FDAClass IIFebruary 19, 2020

FlexTip Plus Epidural Catheterization Kit recall

FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E

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: 71F19A1623 71F19B0507 14F19D0467 71F19G0728 71F19J1893 14F19L0127 71F19A2295 14F19B0224 71F19E1270 71F19G0974 71F19K0694 71F19A2972 14F19D0011 71F19E1868 71F19J0168 71F19K0899 71F19B0343 71F19D2947 71F19F0330 14F19J0132 71F19K2112

Product
FlexTip Plus Epidural Catheterization Kit, Product Code JC-05400-E
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