Arrow International Inc recalls FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK

Recall date

January 15, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1209-2020

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

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.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK