FDA Medical Device Recalls (openFDA)
I-Flow Corporation: ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
- Recall number
- Z-1869-2008
- Recalling firm
- I-Flow Corporation
- Product
- ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
- Status
- Terminated
- Initiated
- 2008-02-12
- Posted
- 2008-09-11
- Terminated
- 2010-02-05
- Reason
- The ON-Q PainBuster, REF PS6504 (lot number 772166), box may contain the wrong product, ON-Q PainBuster, REF PS6502. If the wrong product is used, patients would receive a 2 ml/hr infusion rather than a 5 ml/hr infusion, which could result in inadequate pain relief.
- Root cause
- Other
- Action
- Firm sent letters on 2/12/2008 to affected customers advising of the possibility of an ON-Q PainBuster PS6502 (100 ml x 2 ml/hr) packed inside the ON-Q PainBuster PS6504 outer box. The intent of the letter is as follows: a) Inform customers of the potential for the wrong product inside the box. b) Require customers to inspect lot 772166 to ensure product inside is correct. c) If the product inside the box is correct, then no further action is required. d) If the product inside the box is incorrect, then the customer is advised to contact I-Flow Customer Service in order to exchange their product. Customers are also advised to send the letter to end users if they sold lot 772166 to other customers. Fax back forms will be provided to document customer compliance with the proposed field correction. If you have questions about this recall contact I-Flow Customer Service at 949-206-2700 from 8:00 am - 5:00 pm U.S. Pacific time.
- Quantity
- 345 units shipped
- Distribution
- Internationally - United Kingdom, Germany, Spain, Denmark, Australia, and Italy
- Lot, serial or model codes
- Lot Number: 772166
- 510(k) numbers
- ["K063530"]
- 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