# FDA recall D-0861-2016

> **Baxter Healthcare Corp.** · Class II · drug recall initiated 2016-01-21.

## Product

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015, Product Code 2B0043, NDC 0338-0553-18.

## Reason for recall

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0861-2016
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-01-21
- **Report date:** 2016-06-01
- **Termination date:** 2018-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0861-2016

## Citation

> AI Analytics. FDA recall D-0861-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0861-2016. Source: US FDA. Licensed CC0.

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