Multi-event September 2017 FDA Recall Drug by Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
This Multi-event Class II drug recall was voluntarily initiated by Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company on September 5, 2017 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance. The product was distributed in IA, WI and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0157-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
09-05-2017
01-17-2018
29,232 1 oz bottle
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
IA, WI
12-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 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: 32-005582.
Batch or Lot Expiration Information
Lot# Lot: Z516
Recall Number: D-0158-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
09-05-2017
01-17-2018
22,080 4 oz bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
IA, WI
12-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 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: 32-005583
Batch or Lot Expiration Information
Lot# Lot: A225
Recall Number: D-0160-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
09-05-2017
01-17-2018
96,828 32 oz bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
IA, WI
12-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 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: 32-005587
Batch or Lot Expiration Information
Lot# Lot: A257, EXP 05-20-2018; A258, EXP 05-19-2018; B017, EXP 01-12-2019; B116, B119, EXP 05-03-2019; B120, EXP 05-04-2019; B131, EXP 05-05-2019; Z535, EXP 10-13-2017; Z638, EXP 12-19-2017.
Recall Number: D-0159-2018
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
09-05-2017
01-17-2018
130,740 16 oz bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
IA, WI
12-19-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 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
