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.

FDA recall notice · announced April 15, 2015 · Wallcur

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: United States including Puerto Rico; and Canada
Lot/code information: No unique lot number on product; all Practi-0.9% Sodium Chloride is subject to recall.
Quantity: 18,657 Bags
Status: Terminated
Products in this recall event:
- 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, (D-0434-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.