PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301
FDA device recall Z-1900-2008 · posted 2008-09-22 · Terminated
Recall details
- Recalling firm
- Curlin Medical Llc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 39,366 units for all affected products/models total
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.
- Date initiated
- 2008-05-30
- Date posted
- 2008-09-22
- Date terminated
- 2009-06-11
- Location
- Bch, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUE AMBULATORY VOLUMETRIC INFUSION PUMP (K981816) | Becton Dickinson Curlin, LLC | 1998-12-04 |