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MOOG Medical Devices Group, Curlin Infusion Administration Sets: Class I Recall - Potential for Reverse Flow of Fluid

Fri, 06/01/2012 - 5:31am
U.S. Food & Drug Administration

AUDIENCE: Risk Manager, Patient

ISSUE: 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.

See the Firm Press Release for a listing of affected product codes and lot numbers.

BACKGROUND: Curlin Infusion Administration Sets are used to deliver a variety of medicines and other fluids. Curlin Infusion Administration Sets were distributed in the U.S. between from December 2011 and May 2012.

RECOMMENDATION: 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[05/22/2012 - Recall Notice - FDA]

[05/31/2012 - Press Release - Moog Medical Devices]

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