Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported April 15, 2015
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.
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Wallcur Incorporated recalled Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of … - a critical-severity action.
Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of … was recalled by Wallcur Incorporated in April 15, 2015. Reason: Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.. Check the official notice for the remedy. Verify recall #D-0434-2015 with the FDA Drug before acting.
The recall
Wallcur Incorporated issued this critical-severity FDA Drug recall-Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals..
- Critical
- severity level
- Class I
- classification
- April 15, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0434-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0434-2015) was formally reported on April 15, 2015, with the manufacturer initiating the action on January 6, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Wallcur Incorporated is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 18,657 Bags.
The documented reason for this recall is: Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals. Distribution data in the federal record shows the product reached: United States including Puerto Rico; and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
18,657 Bags
Related Recalls
6
5 from same agency
Product description
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 Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0434-2015 |
| Date reported | April 15, 2015 |
| Date initiated | January 6, 2015 |
| Recalling firm | Wallcur Incorporated |
| Firm location | San Diego, CA |
| Affected scope | 18,657 Bags |
| Distribution | United States including Puerto Rico; and Canada |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0434-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Wallcur Incorporated. Units affected: 18,657 Bags.
Why was this product recalled? ▼
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 15, 2015. Severity: Critical. Recall number: D-0434-2015.
Where was the recalled product distributed? ▼
Distribution: United States including Puerto Rico; and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0434-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported April 15, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.