FDA Recall D-0434-2015
Wallcur Incorporated · San Diego, CA
Class I — life-threatening Terminated 323 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
Reason for recall
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Recall record
- Recall number
D-0434-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- United States including Puerto Rico; and Canada
- Recall initiated
- 2015-01-06
- Classified by FDA Center
- 2015-04-06
- FDA published
- 2015-04-15
- Terminated
- 2015-11-25
- Recalling firm
- Wallcur Incorporated
- Firm location
- San Diego, CA