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Moog Medical Devices Group Announces Voluntary Recall Of Select Curlin Administration Sets Due To Possible Health Risk

Posted May 23 2012 12:27pm
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Contact:
Customer/Consumer:
(800) 970-2337
 

FOR IMMEDIATE RELEASE - May 22, 2012 - Salt Lake City, UT–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):
340-4114 340-4115 340-4126 340-4128 340-4128-V 340-4130 340-4130-V 340-4133
340-4137 340-4144 340-4165 340-4166 340-4173 340-4176

Lot Numbers (Lot numbers are found in the lower right hand corner of the administration set packaging):
CF1127990 CF1134390 CF1200492 CF1202592 CF1205492 CF1208091
CF1127991 CF1134391 CF1200493 CF1204092  CF1206890  CF1208092
CF1127992 CF1133490 CF1200293 CF1204093  CF1206891
CF1129990 CF1134392 CF1200494 CF1203391  CF1205493
CF1130190 CF1134990 CF1200294 CF1204091  CF1206090
CF1130690 CF1134393 CF1201893 CF1203392  CF1206091
CF1130691 CF1135490 CF1201890 CF1203390  CF1206092
CF1130693 CF1135491 CF1201190 CF1204090  CF1208090
CF1131190 CF1135492 CF1201192 CF1204690  CF1206893
CF1131191 CF1200290 CF1202591 CF1204691  CF1207592
CF1130692 CF1200291 CF1202590 CF1205491  CF1207590
CF1132290 CF1200292 CF1201891 CF1204692  CF1207591
CF1132291 CF1200490 CF1201191 CF1205490  CF1207593
CF1133491 CF1200491 CF1201892 CF1205990  CF1209091

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.
 

  • 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 disclaimer icon .

 

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