FDA Recall Terminated

Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

Recall: Z-1401-2012 · Initiated March 20, 2012

Recall

Recall Number
Z-1401-2012
Event Number
61446
Firm
MOOG Medical Devices Group
FEI Number
1000117172
Product Code
FRN
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
March 20, 2012
Posted
April 13, 2012
Terminated
July 26, 2012
Address
4314 Zevex Park Ln, Salt Lake City, UT, 84123-7881

Description

Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.

Reason

Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.

Action

Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.

Distribution

Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,

Quantity

11,628