FDA Recall D-1108-2015

Hospira Inc. · Lake Forest, IL

Class I — life-threatening Terminated 663 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.

Lot / code: Lot # 40-008-JT; Exp. 04/01/16

Quantity: 24,744 flexible container bags

Reason for recall

Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold

Recall record

Recall number: D-1108-2015
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2015-03-11
Classified by FDA Center: 2015-05-28
FDA published: 2015-06-03
Terminated: 2017-01-02
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

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