510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-1869-2011

Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in...

Zevex, Inc. / initiated 2011-02-28 / Terminated / root cause: software
FDA source (opens on fda.gov)

Zevex International, Inc. began a recall of Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and... on . The reason FDA records is "Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1869-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zevex, Inc.
Product
Curlin PainSmart Ambulatory Infusion Pump Provides a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Product code
FRN Pump, Infusion
Reason for recall
Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed.
Root cause tag
software
FDA root cause
Software design
Action
The firm, MOOG, sent an "URGENT DEVICE RECALL NOTIFICATION" letter dated February 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) Identify the affected Pumps: a) If they have an affected pump, fill out and return the enclosed Business Reply Card within five (5) working days. b) If their pump is not affected by this recall, the pump can be used for its intended purposes. 2) Removal of affected Product: a) remove affected products from service and use non-affected pump b) If you do not have an alternate pump available for use, MOOG recommended that they weigh the risks and benefits for delivering medications using the affected pump versus the risk of not using any pump for each patient WARNING: Affected pumps should not be used to deliver critical medications where a delay in therapy could result in serious adverse health effects, injury or death; and affected pumps should not be used with the neonatal population. 3)Should they Have an Affected pump which exhibits Error Code 45 or is used in therapeutic situations specified in the warning, please contact MOOG Customer Service at (800) 970-2337, Monday thru Friday, 7:00am to 5:00pm MST to arrange for a loaner pump and the return of your affected pump. If you have any additional questions regarding this recall, please contact MOOG's Customers Service Department at (800) 970-2337.
Quantity in commerce
918 units
Distribution
Worldwide distribution: USA and countries including: Australia, Canada, Costa Rica, Croatia, Dubai, France, Germany, Ireland, Italy, Japan, Jordan, Kuwait, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, UAE, United Kingdom.
Product codes and lots
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