Product Detail

Product Description 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- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31);
f) 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38),
Rx Only, Baxter, Deerfield, IL 60015

Recall Number D-628-2013

Classification Class II

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;
f) Product code 2B1309: P280149, Exp 8/13

Product Distributed Qty 1,788,292 units

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.

Event Detail

Event Id 65288

Product Type Drugs

Status Ongoing

Recalling Firm
Baxter Healthcare Corp.
City Deerfield
State IL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-21

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide & Puerto Rico