Baxter Auto Syringe AS40 and AS40A Infusion Pump, product code 1M8565 (pumps with drug library option) and product codes
FDA device recall Z-0599-06 · posted 2006-03-07 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
- Action taken
- Important Product Information letters dated 2/8/06 were sent to the AS40 customers via first class mail to the attention of the Director of Nursing. The accounts were informed of the delay in the detection of a downstream occlusion when the AS40 pump is used with large volume syringes at low flow rates. To minimize the occlusion detection times at low flow rates, Baxter recommended that the customers take the following actions: * Use the smallest possible syringe size for the volume of fluid to be delivered; * Select the low occlusion pressure setting to minimize the detection time; * Utilize infusion sets with thick-walled, small bore tubing to minimize the detection time; and * Always verify that the clamping device or stopcock is open in the fluid path prior to starting an infusion.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 17,400 pumps
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-02-08
- Date posted
- 2006-03-07
- Date terminated
- 2010-01-19
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTO SYRINGE AS40A INFUSION PUMP (K940147) | Baxter Corp. | 1994-04-15 |