D-1282-2014 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

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

These dates say when openFDA published the data file and when RegDataLab last loaded it.