Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Sterile Eyewash
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0160-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
All 2017 recalls
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Class II · Moderate risk
Sterile Eyewash
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Other sterility / contamination recalls from 2017
All sterility / contamination recalls
Class II · Moderate risk
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Rocuronium Bromide in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Methadone HCl Injection in all strengths
Lack of sterility assurance.
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