Baxter Healthcare Corp.: 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) 2

Is my product affected?

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-

• Brand SODIUM CHLORIDE

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

What happened

Baxter Healthcare Corp. is recalling specific lots of Sodium Chloride Injection, USP products distributed nationwide and in Puerto Rico due to a manufacturing defect that may allow leakage at the administration port. The defect occurred during the sealing of the closure assembly and affects 1,788,292 units across multiple product codes and lot numbers, with expiration dates ranging from May 2013 to November 2013. The leakage could compromise the sterility of the solution, posing a potential health risk to patients who receive the affected product.

The affected lot numbers vary by product code: Product code 2B1301 includes lots P279943 and P280370; Product code 2B1302 includes lots P280248, P280248A, P280248B, P285346, and P285791; Product code 2B1306 includes lot P285601; Product code 2B1307 includes lot P280347; Product code 2B1308 includes lots P280404, P280404A, P285635, and P285858; and Product code 2B1309 includes lot P280149. The source document does not specify what action affected consumers should take regarding this recall.

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

Hazard

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.

Details from the source

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 Quantity: 1,788,292 units Lot/code info: Lot #: a) Product code 2B1301: P279943, P280370, Exp 7/13; b) Product code 2B1302: P280248, P280248A, P280248B, P285346, P285791, Exp 8/13; c) Product code 2B1306: P285601, Exp 5/13; d) Product code 2B1307: P280347, Exp 8/13; e) Product code 2B1308: P280404, P280404A, P285635, P285858, Exp 11/13; e) Product code 2B1309: P280149, Exp 8/13

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
• 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 Healthcar2013-11-21
• 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