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FDA Medical Device Recalls (openFDA)

I-Flow Corporation: Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065

Recall number
Z-0687-03
Recalling firm
I-Flow Corporation
Product
Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065
Status
Terminated
Initiated
2003-03-04
Posted
2003-03-27
Terminated
2004-04-14
Reason
Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
Root cause
Other
Action
Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.
Quantity
2,832 units
Distribution
CA, OH, WA, TX, UT, SC, MI, IL.
Lot, serial or model codes
Lot 262074
510(k) numbers
["K932740"]
PMA numbers
not on file
Product code
MEB
Firm FEI
3011270181
Firm city
Lake Forest
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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