FDA Medical Device Recalls (openFDA)
Curlin Medical Llc: PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301
- Recall number
- Z-1900-2008
- Recalling firm
- Curlin Medical Llc
- Product
- PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301
- Status
- Terminated
- Initiated
- 2008-05-30
- Posted
- 2008-09-22
- Terminated
- 2009-06-11
- Reason
- 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.
- Root cause
- Other
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Serial Numbers for all affected units: 100074 to 210458
- 510(k) numbers
- ["K981816"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3002936294
- Firm city
- Bch
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28