Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 500106
FDA device recall Z-0687-03 · posted 2003-03-27 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- Reason for recall
- Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
- Action taken
- Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 2,832 units
- Distribution
- CA, OH, WA, TX, UT, SC, MI, IL.
- Date initiated
- 2003-03-04
- Date posted
- 2003-03-27
- Date terminated
- 2004-04-14
- Location
- Lake Forest, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMEPUMP NSF (K932740) | Block Medical, Inc. | 1993-10-06 |