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American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, Lot # 0048 Due to Translucent Visible Particles
Date:2/3/2011

mL Single Dose Vial, with lot # 0048 for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product.  Consumers/distributors/retailers that have product which is being recalled should stop use.

AmericanRegentwill creditaccountsfoall eturned producwith this lot#. Thosewith questionsabout thereturnor ecallprocess, pleasecall our CustomeServiceDepartmenat 1-877-788-3232: Monday thu Friday fom8:30AMto7:00PMEST.Hositals, Home Health Agencies, Emegency ooms, Infusion Centers, Clinics and Healthcare Providers,or patients withproduct quality complains, medicalor ohequestions concerning the useof he product or reasons for his recall should contact the Pofessional SevicesDepartmena1-877-788-3232.Anyadvese reactions experiencedwiththe use of this poduct should be reported to AmericanRegent,Inc.viaemailat pv@luitpold.combyfaxo (610)650-
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SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
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The removable inflation/injection adapter allows the cystoscope to be removed after the catheter is in place. Supplied sterile in peel-open packages. Intended for one-time use....
Gold radiopaque markers indicate the proximal and distal ends of the balloon. Supplied sterile in peel-open packages. Intended for one-time use....
... balloon design allows the ureter to be ... marker at the base of the balloon ... ureteral dilation. Supplied sterile in peel-open packages. ... Vise Handle (plastic), Straight Safety Wire Guide ...
Used retrograde to dilate the ureter and establish a conduit for a flexible ureteroscope. Supplied sterile in peel-open packages. Intended for one-time use....
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