# FDA recall D-1163-2014

> **Baxter Healthcare Corp.** · Class I · drug recall initiated 2013-11-21.

## Product

0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b)  100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA.

## Reason for recall

Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag

## Distribution

Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.

## Key facts

- **Recall number:** D-1163-2014
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-11-21
- **Report date:** 2014-03-26
- **Termination date:** 2016-09-21

- **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-1163-2014

## Citation

> AI Analytics. FDA recall D-1163-2014. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1163-2014. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*