Home / Recalls / Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company / D-0159-2018

D-0159-2018 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
January 17, 2018
Initiation Date
September 5, 2017
Termination Date
December 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
130,740 16 oz bottles

Product Description

Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585

Reason for Recall

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

Distribution Pattern

IA, WI

Code Information

Lot: A259, A260, EXP 05-26-2018; A301, 06-23-2018; B117, B118, EXP 03-02-2019; C005, EXP 01-09-2020; C219, EXP 05-24-2020; Z521, EXP 10-06-2017

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)
  • 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)
  • Z-0715-2019 Class I — Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ (September 5, 2017)