Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Produ
FDA device recall Z-2122-2011 · posted 2011-04-29 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Pumps submitted for service may not have been properly serviced before being returned to the customer.
- Action taken
- Baxter visited the direct accounts starting on 3/24/11 informing them that the affected Flo-Gard pumps may have been released from the preventative maintenance with incorrect accuracy testing. The affected pumps were located, taken out of service and placed in quarantine on the same date. A technician not involved with the previous testing visited both accounts on 3/25/11 and performed preventative maintenance service of the three affected devices, and were found to be within specification.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 3 units
- Distribution
- Puerto Rico
- Date initiated
- 2011-03-24
- Date posted
- 2011-04-29
- Date terminated
- 2011-04-29
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLO-GARD(R) 6201 (K915522) | Baxter Healthcare Corp | 1992-02-28 |