Curlin Medical LLC
Huntington Beach, CA
Curlin Medical Llc appears in FDA device records in Huntington Beach, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 6
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1900-2008 | PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301 | 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. | Terminated | ||
| Z-1899-2008 | Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 | Curlin Medical has investigated five cases of over-delivery/free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow. The firm's investigations have identified the cause of this deformity to have been a result of the pump being dropped with the door (p | Terminated | ||
| Z-1898-2008 | Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101 | 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. | Terminated | ||
| Z-1897-2008 | Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001 | Over-delivery/free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow. | Terminated | ||
| Z-1896-2008 | Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number: 340-1001 | 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. | Terminated | ||
| Z-1129-2007 | Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. | The Administration Sets may leak at the reservior bag. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain