Z-0687-03
Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part...
Halyard Health / initiated 2003-03-04 / Terminated
I-Flow Corporation began a recall of Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065 on . The reason FDA records is "Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0687-03
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Halyard Health
- Product
- Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065
- Product code
- MEB Pump, Infusion, Elastomeric
- Reason for recall
- Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
- FDA root cause
- Other
- Action
- Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.
- Quantity in commerce
- 2,832 units
- Distribution
- CA, OH, WA, TX, UT, SC, MI, IL.
- Product codes and lots
- Lot 262074
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
