Arrow International Inc: Medical Device Recall in 2020 - (Recall #: Z-1212-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME

Product Classification:

Class II

Date Initiated: January 15, 2020

Date Posted: February 19, 2020

Recall Number: Z-1212-2020

Event ID: 84726

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.

Status: Terminated

Product Quantity: 343,105 total

Code Information:

Lots: 71F19A1324 71F19C2255 71F19E3165 71F19H1740 71F19K0132 71F19B0614 71F19C2567 71F19G0092 71F19H1742 71F19K0134 71F19C2254 71F19E0766 71F19G1018 71F19H2570 71F19L0033

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated