MOOG Medical Devices Group, Curlin Infusion Administration Sets
Recall Class: Class I
Date Recall Initiated: May 18, 2012
Product: Curlin Infusion Administration Sets
To find the list of REF Codes and Lot Numbers, see the link to the Firm Press Release under Additional Links below.
REF Codes are found on the top right hand corner of the administration set packaging. Lot Numbers are found on the lower right hand corner of the administration set packaging.
Range of distribution dates: Curlin Infusion Administration Sets were distributed in the U.S. between from December 2011 and May 2012.
Use: The Curlin Infusion Administration Sets are used to deliver a variety of medicines and other fluids.
MOOG Medical Devices Group
4314 Zevex Park Lane
Salt Lake City, Utah 84123
Reason for Recall: There is a potential for a reverse pump segment in the administration set. This malfunction could reverse the flow of fluid or medicines backwards from what was intended. This may cause blood loss, an under-delivery of prescribed medicines or fluids, or a potential delay in therapy. Use of the affected administration sets may cause serious adverse health consequences, including death.
Patients in a home environment can contact Moog Customer Advocacy at 1-800-970-2337, prompt #7.
Healthcare Facilities/Distributors can contact the company at 1-800-970-2337, prompt #7.
FDA District: Denver
On Monday, May 21, 2012, the firm notified patients, healthcare facilities, pharmacies, and distributors through their press release (see link below) and by certified letter.
The letter instructed customers and distributors to do the following:
Patients in a home environment: Contact your home healthcare provider or clinician for proper handling and the replacement process of your affected administration set(s).
Healthcare facilities/Pharmacies: Contact your distributor for proper handling and the replacement process of the affected administration sets.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.