Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product
FDA device recall Z-0134-2012 · posted 2011-10-28 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.
- Action taken
- A Baxter Healthcare technician initially notified the sole customer on August 26, 2011 of the defective product and requested that the product be quarantined. On September 14, 2011 a technician visited the site to correct the problem observed on the Flo-Gard Infusion Pump. All required tests were performed and the results were found acceptable.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 1 unit
- Distribution
- Distributed only in Puerto Rico.
- Date initiated
- 2011-08-26
- Date posted
- 2011-10-28
- Date terminated
- 2011-10-31
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLO-GARD(R) 6301 (K915523) | Baxter Healthcare Corp | 1992-02-28 |