FDA Drug recall D-0861-2016
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporat…
- FDA Drug
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporat… by Baxter Healthcare, citing lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0861-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-21 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Reason
Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Identifiers
| ndc | 0338-0553-11 |
|---|---|
| ndc | 0338-0553-18 |
| code_info | Lot #: P337857, Exp 07/31/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0861-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.