Recalls / —
—#37341
Product
Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K993387
- Affected lot / code info
- product codes 2L3107 and 2L3107R, all serial numbers
Why it was recalled
Potential failures of the pump due to upstream occlusion alarms, electro-static discharge, system error 32 or 33, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump.
Root cause (FDA determination)
Other
Action the firm took
Baxter mailed Urgent Device Correction letters dated 2/10/05 to the domestic accounts on 2/10/05 via first class mail, to the attention of the Director of Nursing, advising them of the following hardware problems and software anomalies and providing workarounds for each. There are potential failures of the pump due to upstream occlusion alarms, electro-static discharge, Key-Only security mode (previously covered by letter dated 4/10/02), system error 32 or 33 codes, history printout errors and fluid volume in 'Use Previous Rx' when priming through the pump. The accounts were advised that as soon as revised software and hardware is available, Baxter would modify the pumps at no additional charge to the consignee. Any questions were directed to their Baxter Medication Delivery Product Information Center at 1-800-933-0303.
Recalling firm
- Firm
- Baxter Healthcare Corp. Rt.
- Address
- 120 & Wilson Rd, Round Lake, Illinois 60073
Distribution
- Distribution pattern
- Nationwide including Puerto Rico, and internationally through Baxter subsidiaries in Canada, Chile, Hong Kong, Kuwait and Saudi Arabia.
Timeline
- Recall initiated
- 2005-02-10
- Posted by FDA
- 2005-11-16
- Terminated
- 2008-11-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #37341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.