Health Update: 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

Moog Medical Devices Group has issued a 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):

Lot Numbers (Lot numbers are found in the lower right hand corner of the administration set packaging):

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, the company has not received any reports injury or death as a result of this issue. The company has identified and corrected the root cause by immediately initiating a supplier corrective action request (SCAR) and implementing additional preventative measures.

Direct customers and distributors will be notified of the process for obtaining replacement administration sets. Patients in a home environment should 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.

Any adverse events that may be related to the use of the affected products should be reported to the FDA's MedWatch Adverse Event Reporting program.  The report may be made by phone at 1-800-FDA-1088, online at www.fda.gov/MedWatch/report.htm, or by returning the postage paid FDA form 3500.  The form may be downloaded from www.fda.gov/MedWatch/getforms.htm and mailed to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or faxed to 1-800-FDA- 0178.

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The Monterey County Health Department releases notices of recalls and market withdrawal from the firms involved as a service to Monterey County residents, the media and other interested parties.  The Health Department does not endorse either the product or the company.