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FDA Medical Device Recalls (openFDA)

I-Flow Corporation: Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)

Recall number
Z-0741-03
Recalling firm
I-Flow Corporation
Product
Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)
Status
Terminated
Initiated
2003-03-18
Posted
2003-04-18
Terminated
2003-11-20
Reason
Overinfusion due to misassembly.
Root cause
Other
Action
Recall letter was sent to sole distributor, B Braun FRance by email on 3/18/2003. Return of stock and subrecall was requested. Consignee has acknowledged implementing subrecall.
Quantity
2638 units
Distribution
Only in France to distributor B. Braun Medical, France
Lot, serial or model codes
Lot numbers 04434366/2A2469 and 04434367/2A2470.
510(k) numbers
["K991513"]
PMA numbers
not on file
Product code
not on file
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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