Why it was recalled
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
IA, WI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0160-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 5, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 96,828 32 oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Original FDA data
Every field from FDA enforcement report D-0160-2018, exactly as published.
Show all FDA fields
- City
- Vernon Hills
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78369
- Address
- 330 Corporate Woods Pkwy
- 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.
- Postal code
- 60061-3107
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0160-2018
- Classification
- Class II
- Recalling firm
- Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
- Product quantity
- 96,828 32 oz bottles
- Termination date
- Dec 19, 2018
- Reason for recall
- Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- IA, WI
- Recall initiation date
- Sep 5, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2018