Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company: Medical Device Recall in 2018 - (Recall #: Z-0490-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Product Classification:

Class II

Date Initiated: September 5, 2017

Date Posted: November 28, 2018

Recall Number: Z-0490-2019

Event ID: 81399

Reason for Recall:

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Status: Terminated

Product Quantity: 10,440

Code Information:

Model # FB-A-400-107 Lot Number: 4J006

Distribution Pattern:

AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI

Voluntary or Mandated:

Voluntary: Firm initiated