# FDA recall D-628-2013

> **Baxter Healthcare Corp.** · Class II · drug recall initiated 2013-05-21.

## Product

Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41; d) 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48); e) 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31); f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015

## Reason for recall

Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

## Distribution

Nationwide & Puerto Rico

## Key facts

- **Recall number:** D-628-2013
- **Recalling firm:** Baxter Healthcare Corp.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-21
- **Report date:** 2013-07-10
- **Termination date:** 2015-06-18

- **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-628-2013

## Citation

> AI Analytics. FDA recall D-628-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-628-2013. Source: US FDA. Licensed CC0.

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