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Moog Medical Devices Group Recalls IV Sets for Reverse Fluid Flow


5/25/2012 8:40:18 AM

SALT LAKE CITY, UT -- (Marketwire) -- 05/22/12 -- Moog Medical Devices Group (MMDG) is issuing a voluntary recall for certain lots of Curlin Intravenous Administration Sets. Use of the affected sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the affected administration sets may cause a potential risk of serious injury or death.

The following REF (catalog) and lot numbers, which were sold and distributed in the U.S. between December 2011 and May 2012, are included in the recall:

REF Code (REF Codes are found in the top right hand corner of the administration set packaging):

Patient safety and product quality are MMDG's first priorities. The recall was initiated as a result of the discovery of a reverse pump segment by customers and reported to Moog. To date, Customer complaints have identified (3) three out of 544,900 suspect sets manufactured for the United States. Despite the potential for reverse flow when using an affected set, MMDG has not received any reports injury or death as a result of this issue. MMDG has identified and corrected the root cause by immediately initiating a supplier corrective action request (SCAR) and implementing additional preventative measures.

MMDG has notified the U.S. Food and Drug Administration and is working with them to coordinate recall activities. Direct customers and distributors will be notified of the process for obtaining replacement administration sets. Patients in a home environment, please contact your home healthcare provider or clinician for proper handling and the replacement process of your affected set(s). For additional questions, contact Moog Customer Advocacy at (800) 970-2337.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: http://www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

Moog Inc. is a worldwide designer, manufacturer, and integrator of precision control components and systems. Moog's high-performance systems control military and commercial aircraft, satellites and space vehicles, launch vehicles, missiles, automated industrial machinery, wind energy, marine and medical equipment. Additional information about the company can be found at www.moog.com.

Contact:

Ann Marie Luhr

716-687-4225

MOOG INC.

EAST AURORA, NEW YORK 14052

TEL - 716/652-2000

FAX -716/687-4457



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