FDA recall Z-1211-2020

Product

FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1

Reason for recall

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.

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.

Key facts

Status

Terminated

Initiation date

2020-01-15

Report date

2020-02-19

Termination date

2023-03-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1211-2020