Baxter Healthcare Corp.: 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 plas

Is my product affected?

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 Healthcar

• Brand SODIUM CHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corp. is voluntarily recalling 0.9% Sodium Chloride Injection, USP in 50 mL and 100 mL single-dose VIAFLEX plastic containers due to the presence of particulate matter in the solutions. The contamination includes polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene, and human hair embedded in the plastic bags. A total of 716,544 containers were distributed nationwide, in Puerto Rico, Singapore, Saudi Arabia, and the United Arab Emirates across four specific lot numbers with expiration dates ranging from April 2014 to August 2014.

The recalled product codes are 2B1308 (50 mL containers, NDC 0338-0049-31) and the 100 mL containers associated with lots P292326, P293993, and P293514. The source document does not specify what actions affected consumers or healthcare providers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 716,544 containers Lot/code info: Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 600152013-05-21
• 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) 2B1308-2013-05-21
• SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 9186102018-11-15
• SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-20, Product code 9186202018-11-15
• 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-102022-10-11

All FDA (Drug enforcement) recalls