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.
This recall has been terminated (originally issued September 11, 2008).
- Company
- I-Flow Corporation
- Recall Initiated
- February 12, 2008
- Posted
- September 11, 2008
- Terminated
- February 5, 2010
- Recall Number
- Z-1869-2008
- Quantity
- 345 units shipped
- Firm Location
- Lake Forest, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Internationally - United Kingdom, Germany, Spain, Denmark, Australia, and Italy
Lot / Code Info
Lot Number: 772166
Root Cause
Other
Action Taken
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.