I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around s
FDA device recall Z-2860-2011 · posted 2011-07-28 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 96,892 units total (95,637 units in US)
- Distribution
- Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.
- Date initiated
- 2011-04-15
- Date posted
- 2011-07-28
- Date terminated
- 2012-08-09
- Location
- Lake Forest, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP (K063530) | I-Flow Corp. | 2007-01-26 |