Arrow International Inc: Medical Device Recall in 2020 - (Recall #: Z-1197-2020)

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:

EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-04

Product Classification:

Class II

Date Initiated: January 15, 2020

Date Posted: February 19, 2020

Recall Number: Z-1197-2020

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: 71F19B0678 71F19C1428 71F19E1149 71F19G0313 71F19J0072 71F19L0492 71F19B2751 71F19D0558 71F19E1781 71F19G2388 71F19J1370 71F19L0493 71F19C0778 71F19D2449 71F19F0737 71F19H1817 71F19K2849

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