Recalls / —
—#97698
Product
Hospira Power cord use on Symbiq One-Channel infuser and Symbiq Two-Channel infuser. Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K051550
- Affected lot / code info
- Power cord part number: HSP3306-E07. Used on List No. 16026 - Symbiq One Channel infuser; List No. 16027 - Symbiq Two-Channel infuser List number configurations: 16026-04-01/03/04, 51/52,. 53/54, 79/80, 81/82, 83/84/ 87/88; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88; 16026-13-25/26, 53/54; 16027-13-25/26, 53/54.
Why it was recalled
Complaints of broken, bent or missing prongs, charring, sparks, visible smoke, burnt smell have been reported on Symbiq AC Power cords.
Root cause (FDA determination)
Component design/selection
Action the firm took
Hospira Recall notification letters were sent by Federal Express on November 1, 2010.
Recalling firm
- Firm
- Hospira Inc
- Address
- 755 Jarvis Dr, Morgan Hill, California 95037-2810
Distribution
- Distribution pattern
- Nationwide distribution and to Australia, Canada, and Malaysia.
Timeline
- Recall initiated
- 2010-10-27
- Posted by FDA
- 2011-03-08
- Terminated
- 2013-11-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #97698. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.