Curlin Intravenous Administration Sets have been recalled over bleeding risk, the U.S. Food & Drug Administration (FDA) just announced. The Curlin Intravenous Administration Sets are manufactured by Moog Medical Devices Group (MMDG)
Use of the recalled intravenous administration sets may cause desanguination (blood loss), an under-delivery of prescribed medication/fluid, or a potential delay in therapy. Continued use of the recalled medical devices may lead to a potential risk of serious injury or death.
The recalled Curlin Intravenous Administration Sets were sold and distributed in the United States between December 2011 and May 2012.
The extensive list of Lot Numbers involved with these recalled medical devices can be accessed on the FDA’s web site at: http://www.fda.gov/Safety/Recalls/ucm305208.htm. Lot numbers are found in the lower, right-hand corner of the administration set packaging. The following REF (catalog) numbers are involved and can be located on 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
MMDG indicated that the recall was initiated following customers’ discoveries of a reverse pump segment. To date, and based on customer complaints, three suspect sets have been identified; no reports of injury or death have been received. MMDG said it has identified and corrected the root cause by immediately initiating a supplier corrective action request (SCAR) and implementing additional preventative measures. MMDG is collaborating with the FDA on recall activities.
Direct customers and distributors will be notified of the process for obtaining replacement administration sets. Patients in a home environment are advised to contact their healthcare provider or clinician for proper handling and the replacement process. Moog Customer Advocacy can be reached, toll-free, at 1.800.970.2337. Adverse reactions or quality problems may also be reported to FDA’s MedWatch Adverse Event Reporting program: Online; by regular mail, use postage-paid FDA form 3500 available here and mail to MedWatch 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or by fax to 1.800.FDA.0178.
