Drug 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.
D-1163-2014
Product summary
- Event
- Event 67092
- Status
- Terminated
- Classification
- Class I
- Quantity
- 716,544 containers
- Official record key
drug-enforcement:D-1163-2014
Official wording
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
Code information: Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14
Distribution pattern: Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter