FDA Medical Device Recalls (openFDA)
I-Flow Corporation: I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
- Recall number
- Z-0358-2007
- Recalling firm
- I-Flow Corporation
- Product
- I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
- Status
- Terminated
- Initiated
- 2006-11-29
- Posted
- 2007-01-18
- Terminated
- 2009-12-11
- Reason
- The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
- Root cause
- Other
- Action
- A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory. A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.
- Quantity
- 3475
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot numbers: 662449 & 662742
- 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
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