Curlin Medical Llc PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301
Brand
Curlin Medical Llc
Lot Codes / Batch Numbers
Serial Numbers for all affected units: 100074 to 210458
Products Sold
Serial Numbers for all affected units: 100074 to 210458
Curlin Medical Llc is recalling PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 due to Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deform. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.
Recommended Action
Per FDA guidance
On May 30, 2008, Curlin Medical began distribution of a "Voluntary Field Correction Advisory Notice" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the "caution" statement related to dropped pumps to a "warning" statement, and (3) A warning label to be located on the pump: "Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use". A toll free number (888-287-5999) was given for customers experiencing issues that require immediate assistance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026