FDA Medical Device Recalls (openFDA)
I-Flow Corporation: Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
- Recall number
- Z-0709-03
- Recalling firm
- I-Flow Corporation
- Product
- Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
- Status
- Terminated
- Initiated
- 2003-03-05
- Posted
- 2003-04-03
- Terminated
- 2004-12-01
- Reason
- Wrong component may result in over infusion of medications.
- Root cause
- Other
- Action
- Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product.
- Quantity
- 5,808 units
- Distribution
- States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa.
- Lot, serial or model codes
- Lot numbers: 262111 (manufactured June 2002, expires May 2005) 282233 (manufactured August 2002, expires July 2005)
- 510(k) numbers
- ["K923875"]
- PMA numbers
- not on file
- Product code
- FRN
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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