D-1163-2014 Class I Terminated
FDA drug recall D-1163-2014 was initiated by Baxter Healthcare Corp. on Nov 21, 2013 and is designated Class I. 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… The recall status is terminated (terminated Sep 21, 2016). Affected quantity: 716,544 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 26, 2014
- Initiation Date
- Nov 21, 2013
- Termination Date
- Sep 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 716,544 containers
Product Description
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 Pattern
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Code Information
Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1163-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026