Reported Jul 10, 2013 · Terminated
Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b)…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
6 of 6 products
| Model / number | Product as published |
|---|---|
2B1301- | 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11) |
| — | 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18) |
| — | 2B1306- 50 mL in Viaflex Single Pack (NDC 0338-0049-41 |
| — | 2B1307- 100mL in Viaflex Single Pack (NDC 0338-0049-48) |
| — | 2B1308- 50 ML in Viaflex Multi Pack (NDC 0338-0049-31) |
| — | 2B1309- 100mL in Viaflex Multi Pack (NDC 0338-0049-38), Rx Only, Baxter, Deerfield, IL 60015 |
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 2B1301P279943, P280370, Exp 7/13 2B1302P280248, P280248A, P280248B, P285346, P285791, Exp 8/13 2B1306P285601, Exp 5/13 2B1307P280347, Exp 8/13 2B1308P280404, P280404A, P285635, P285858, Exp 11/13 2B1309P280149, Exp 8/13 - Amount recalled
- 1,788,292 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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