FDA recall D-1282-2014

Product

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

nationwide

Key facts

Status

Terminated

Initiation date

2014-04-21

Report date

2014-05-07

Termination date

2015-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1282-2014