Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter The Curlin Ambulatory Infusion Pump System with

FDA device recall Z-1407-2012 · posted 2012-04-13 · Terminated

Recall details

Recalling firm

MOOG Medical Devices Group

Reason for recall

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 taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Quantity affected

693

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 Un

Date initiated

2012-03-20

Date posted

2012-04-13

Date terminated

2012-07-26

Location

Salt Lake City, UT