ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF… recallZ-1869-2008 · I-Flow Corporation · initiated Feb 12, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from I-Flow Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1869-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 12, 2008
- Posted by the FDA
- Sep 11, 2008
- Recalling firm
- I-Flow Corporation
- Quantity
- 345 units shipped
- Product code
- MEB
- FDA submissions
- K063530
- Distribution
- Internationally - United Kingdom, Germany, Spain, Denmark, Australia, and Italy
Product description
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.
Code information (models, lots, serial numbers)
Lot Number: 772166
Other devices under the same FDA submission
69 devices cleared under K063530 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ON-Q* Pain Relief System with SELECT-A-FLOW 13472Avanos Medical, Inc. · Pump, infusion, elastomeric73 reports
- Halyard 13472Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC68 reports
- ON-Q* Pain Relief System with SELECT-A-FLOW* 13476Avanos Medical, Inc. · Pump, infusion, elastomeric21 reports
- ON-Q* C-bloc with SELECT-A-FLOW* and ONDEMAND* 13474Avanos Medical, Inc. · Pump, infusion, elastomeric20 reports
- Halyard 13476Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC1 death19 reports
- Halyard 13685Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC19 reports
- Halyard 13477Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC1 death14 reports
- Halyard 13474Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC9 reports
- Halyard 13483Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC9 reports
- ON-Q* C-Bloc with SELECT-A-FLOW* and ONDEMAND* 13473Avanos Medical, Inc. · Pump, infusion, elastomeric6 reports
- ON-Q* Pain Relief System 13630Avanos Medical, Inc. · Pump, infusion, elastomeric6 reports
- Halyard 13473Avanos Medical, Inc. · PUMP, INFUSION, ELASTOMERIC6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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