FDA recall D-0434-2015

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.

Distribution

United States including Puerto Rico; and Canada

Key facts

Status

Terminated

Initiation date

2015-01-06

Report date

2015-04-15

Termination date

2015-11-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0434-2015