D-1282-2014 Class II Terminated
FDA drug recall D-1282-2014 was initiated by Baxter Healthcare Corp. on Apr 21, 2014 and is designated Class II. Reason for recall: Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation. The recall status is terminated (terminated Feb 24, 2015). Affected quantity: 211,752 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2014
- Initiation Date
- Apr 21, 2014
- Termination Date
- Feb 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211,752 bottles
Product Description
0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0048-04.
Reason for Recall
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Distribution Pattern
nationwide
Code Information
Lot # Gl09272; Exp 09/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1282-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026