The Recall Desk
SevereFDA (Drugs)·D-0434-2015·Announced 2015-04-15

Wallcur Recalls Practi-0.9% Sodium Chloride Bags Due to Non-Sterility

Wallcur Incorporated is recalling Practi-0.9% Sodium Chloride bags because they were manufactured in a non-sterile facility and are not intended for human or animal use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric, despite the product being intended for simulation rather than direct human use.

Plain-English summary

Wallcur Incorporated is recalling 18,657 bags of Practi-0.9% Sodium Chloride in 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL sizes. The product is a simulation aid produced in China and distributed in the United States, including Puerto Rico, and Canada. The recall is due to non-sterility, as the product was made in a non-sterile facility and is not intended for use in humans or animals.

The affected product includes NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, and 5108-0954-73. There is no unique lot number on the product, so all Practi-0.9% Sodium Chloride bags are subject to the recall. The FDA has classified this as a Class I recall.

Consumers and healthcare facilities should stop using the product immediately and contact Wallcur Incorporated for instructions on how to return or dispose of the recalled items.

The recalled product

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.
Affected units
18,657

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • No unique lot number on product
  • all Practi-0.9% Sodium Chloride is subject to recall.

Distribution

Distributed in 1 state: