FDA Drug recall D-1163-2014
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) an…
- FDA Drug
- Class I
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class I recall of 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) an… by Baxter Healthcare, citing 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 fibe….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1163-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-11-21 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
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
Identifiers
| ndc | 0338-0049-01 |
|---|---|
| ndc | 0338-0049-02 |
| ndc | 0338-0049-03 |
| ndc | 0338-0049-04 |
| ndc | 0338-0049-10 |
| ndc | 0338-0049-41 |
| ndc | 0338-0049-11 |
| ndc | 0338-0049-31 |
| ndc | 0338-0049-48 |
| ndc | 0338-0049-18 |
| ndc | 0338-0049-38 |
| ndc | 0338-0043-03 |
| ndc | 0338-0043-04 |
| code_info | Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1163-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.