Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301

FDA Recall Z-1900-2008 · Posted 2008-09-22

Recalling FirmCurlin Medical Llc
Recall StatusTerminated
Product CodeFRN
Date Initiated2008-05-30
Date Terminated2009-06-11
Product Quantity39,366 units for all affected products/models total

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981816CUE AMBULATORY VOLUMETRIC INFUSION PUMPBecton Dickinson Curlin, LLC · 1998-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑