Moog Recalls Curlin Infusion Pumps Due to Calibration Defect
Moog is recalling specific Curlin infusion pumps because calibration errors may cause them to deliver medication faster than programmed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may cause over-delivery of medication, representing a risk of harm where specific injuries or illnesses have not yet been reported in the source text.
Plain-English summary
MOOG Medical Devices Group is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps. The affected units were manufactured or serviced by MMDG between March 18, 2015, and November 6, 2015. The recall involves 11,472 units distributed in the United States, Guam, and several international countries.
The recall is being conducted because the master pumps used to calibrate these devices were out of tolerance. As a result, the affected infusion pumps may deliver medications and solutions at a rate 1.2 to 6.8 percent faster than programmed. This defect could lead to an over-delivery of medication to patients.
Healthcare facilities and users should identify affected units by checking the manufacturing or service dates and catalog numbers (340, 360, or 340-4038). Users should contact MOOG Medical Devices Group for instructions on how to address the calibration issue.
The recalled product
- Product
- Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, c
- Manufacturer
- MOOG Medical Devices Group
- Category
- Medical Device — Infusion Pump
- Affected units
- 11,472
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- All manufactured or serviced by MMDG between March 18
- 2015 and November 6
- 2015. Curlin 4000
- catalog number 340
- Curlin 6000
- 6000 CMS
- and PainSmart IOD
- catalog number 360
- and Curlin Pump Calibration Set
- catalog number 340-4038.
Distribution
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