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Recall Observatory FDA recall evidence

Drug 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

D-0160-2018

September 05, 2017

Class II

Product summary

Firm
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Event
Event 78369
Status
Terminated
Classification
Class II
Quantity
96,828 32 oz bottles
Official record key
drug-enforcement:D-0160-2018

Official wording

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

Code information: 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.

Distribution pattern: IA, WI

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of sterility