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I-Flow ON-Q with Select-A-Flow Pumps recallZ-2860-2011 · I-Flow Corporation · initiated Apr 15, 2011

Terminated All recalls posted in July 2011

Is my device affected?

  1. 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.
  2. 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.
  3. 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 recall was initiated because I Flow became aware that a small percentage of ON-Q Pump with Select A Flow may develop a minor leak with a flow rate controller. There may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.

FDA root cause category: Process control

What the company is doing

I-Flow Corporation sent an "Important Voluntary Market Withdrawal Notice" dated May 12, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.

Recall details

Recall number
Z-2860-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 15, 2011
Posted by the FDA
Jul 28, 2011
Recalling firm
I-Flow Corporation
Quantity
96,892 units total (95,637 units in US)
Product code
MEB
FDA submissions
K063530
Distribution
Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.

Product description

I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. It is a controller that allows the user to regulate the amount of medication that is dispensed.

Code information (models, lots, serial numbers)

Model Numbers:  CB004, CB005, CB006, CB6004, CB6007, P100X2-14, P200X2-14, P270X1-7, P400X2-14, P400X1-7+5/60, P400X2-14+5/30, P600X2-14, P600X1-7D, and SAF01.   Part Numbers: 5001481,5001521,5001651,5001771,5001780,5001788,5001799, 5001807,5001808,5001809,5001810,5001811,5001830, and 5001831.   Specific lot numbers: 122215, 132435, 132464, 932165, and 962434. Also, all lot numbers that begin with:  98 (except 982631 and 982645),   99,   9A (except 9A2913),   9B,   9C,   01, 02, 03, 04, 05, 06, 07, 08, 09,   0A,   0B,   and 0C (except 0C2949 and 0C2950).

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.

Sources and updates

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