Medications & Supplements/Over-the-Counter

Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company: Sterile Eyewash Recalled for Leaking Containers and Infection Risk

Agency Publication Date: January 5, 2018

Summary

Approximately 278,880 units of Sterile Eyewash (isotonic phosphate buffered saline solution) manufactured by Medex Cardio-Pulmonary Inc. (Smiths Medical Company) are being recalled. The recall includes various sizes including 1 oz, 4 oz, 16 oz, and 32 oz bottles because the containers may leak, which compromises the sterility of the solution. This defect could expose users to infectious agents when using the eyewash to treat their eyes.

Risk

Leaking containers allow bacteria and other contaminants to enter the bottle, meaning the eyewash is no longer sterile. Using non-sterile solution in the eyes can lead to serious eye infections or exposure to infectious agents.

What You Should Do

Identify if you have the affected Sterile Eyewash by checking the bottle size and lot numbers: 1 oz (Lot Z516), 4 oz (Lot A225), 16 oz (Lots A259, A260, A301, B117, B118, C005, C219, Z521), or 32 oz (Lots A257, A258, B017, B116, B119, B120, B131, Z535, Z638).
Check the expiration dates on the 16 oz and 32 oz bottles, ranging from October 2017 through January 2020.
Stop using any eyewash from these affected lots immediately, even if the bottle does not appear to be leaking.
Contact your healthcare provider or pharmacist for guidance if you have used these products and are experiencing eye irritation or signs of infection.
Return any unused product to the place of purchase for a refund and contact Medex Cardio-Pulmonary Inc. (Smiths Medical Company) for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Sterile Eyewash (1 oz.)

Model:

32-005582

Lot Numbers:

Z516

Product: Sterile Eyewash (4 oz.)

Model:

32-005583

Lot Numbers:

A225

Product: Sterile Eyewash (16 oz.)

Model:

32-005585

Lot Numbers:

A259 (Exp 05-26-2018)

A260 (Exp 05-26-2018)

A301 (Exp 06-23-2018)

B117 (Exp 03-02-2019)

B118 (Exp 03-02-2019)

C005 (Exp 01-09-2020)

C219 (Exp 05-24-2020)

Z521 (Exp 10-06-2017)

Date Ranges: October 2017 - May 2020

Product: Sterile Eyewash (32 oz.)

Model:

32-005587

Lot Numbers:

A257 (Exp 05-20-2018)

A258 (Exp 05-19-2018)

B017 (Exp 01-12-2019)

B116 (Exp 05-03-2019)

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)

Date Ranges: October 2017 - May 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78369

Status: Resolved

Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Manufactured In: United States

Units Affected: 4 products (29,232 1 oz bottle; 22,080 4 oz bottles; 130,740 16 oz bottles; 96,828 32 oz bottles)

Distributed To: Iowa, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Sterile Eyewash by checking the bottle size and lot numbers: 1 oz (Lot Z516), 4 oz (Lot A225), 16 oz (Lots A259, A260, A301, B117, B118, C005, C219, Z521), or 32 oz (Lots A257, A258, B017, B116, B119, B120, B131, Z535, Z638).

Check the expiration dates on the 16 oz and 32 oz bottles, ranging from October 2017 through January 2020.

Stop using any eyewash from these affected lots immediately, even if the bottle does not appear to be leaking.

Contact your healthcare provider or pharmacist for guidance if you have used these products and are experiencing eye irritation or signs of infection.

Return any unused product to the place of purchase for a refund and contact Medex Cardio-Pulmonary Inc. (Smiths Medical Company) for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Sterile Eyewash (1 oz.)

Model:

32-005582

Lot Numbers:

Z516

Product: Sterile Eyewash (4 oz.)

Model:

32-005583

Lot Numbers:

A225

Product: Sterile Eyewash (16 oz.)

Model:

32-005585

Lot Numbers:

A259 (Exp 05-26-2018)

A260 (Exp 05-26-2018)

A301 (Exp 06-23-2018)

B117 (Exp 03-02-2019)

B118 (Exp 03-02-2019)

C005 (Exp 01-09-2020)

C219 (Exp 05-24-2020)

Z521 (Exp 10-06-2017)

Date Ranges: October 2017 - May 2020

Product: Sterile Eyewash (32 oz.)

Model:

32-005587

Lot Numbers:

A257 (Exp 05-20-2018)

A258 (Exp 05-19-2018)

B017 (Exp 01-12-2019)

B116 (Exp 05-03-2019)

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)

Date Ranges: October 2017 - May 2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78369

Status: Resolved

Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Manufactured In: United States

Units Affected: 4 products (29,232 1 oz bottle; 22,080 4 oz bottles; 130,740 16 oz bottles; 96,828 32 oz bottles)

Distributed To: Iowa, Wisconsin