MOOG Medical Devices Recalls Curlin Infusion Administration Sets
MOOG Medical Devices Group is recalling 12,000 Curlin Infusion Administration Sets due to an incomplete previous recall regarding unclearable Air-In-Line alarms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a functional defect (unclearable alarm) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
MOOG Medical Devices Group is recalling 12,000 Curlin Infusion Administration Sets (REF 340-4165, Sterile EO). This action is being taken because specific lots were inadvertently omitted from a previous FDA-processed recall initiated on January 25, 2011. The original recall was related to customer reports of unclearable Air-In-Line alarms when using specific lot numbers of Curlin Administration Sets with Curlin Ambulatory Infusion Pumps.
The affected product is the Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, which provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous, and Intravenous applications. The recall covers lots with the following codes: 340-4166/CF1022906, 340-4128-V/CRF10082001, and 340-4165/CF1022905.
The product was distributed nationwide, including California. Users of these infusion sets should check their inventory for the specific lot numbers listed above and contact MOOG Medical Devices Group for instructions on how to return or replace the affected units.
The recalled product
- Product
- ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for…
- Manufacturer
- MOOG Medical Devices Group
- Affected units
- 12,000
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 (3)
- Product Code/Lot Number: 340-4166/CF1022906
- 340-4128-V/CRF10082001
- 340-4165/CF1022905.
Distribution
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