FDA recall D-0160-2018

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

Reason for recall

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

Distribution

IA, WI

Key facts

Status

Terminated

Initiation date

2017-09-05

Report date

2018-01-17

Termination date

2018-12-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0160-2018