Home / Recalls / Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company / Z-0490-2019

Z-0490-2019 Class II Terminated

Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company — Vernon Hills, IL

Recall Details

Product Type
Devices
Report Date
November 28, 2018
Initiation Date
September 5, 2017
Termination Date
September 23, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,440

Product Description

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Reason for Recall

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

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

Code Information

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

Other recalls by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

  • D-0157-2018 Class II — Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 (September 5, 2017)
  • D-0158-2018 Class II — Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 (September 5, 2017)
  • D-0160-2018 Class II — Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 (September 5, 2017)
  • D-0159-2018 Class II — Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 (September 5, 2017)
  • Z-0718-2019 Class I — Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ (September 5, 2017)
  • Z-0713-2019 Class I — Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ (September 5, 2017)
  • Z-0712-2019 Class I — Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ (September 5, 2017)
  • Z-0721-2019 Class I — Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿ (September 5, 2017)
  • Z-0714-2019 Class I — Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ (September 5, 2017)
  • Z-0722-2019 Class I — Medline Prefilled 550 ml Sterile¿¿ ¿ (September 5, 2017)