I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742
FDA device recall Z-0358-2007 · posted 2007-01-18 · Terminated
Recall details
- Recalling firm
- I-Flow Corporation
- Reason for recall
- The pump flow rate labeling may not match the package labeling. The label on filter may not match the label on the top of the pump or the package labeling.
- Action taken
- A Recall Notification Letter was faxed to affected customers on November 29, 2006. Affected customers were notified of the identity of product subject to recall, the reason for recall, and instructed to quarantine immediately any remaining inventory. A Customer Response (FAX back) form was included with the Recall Notification Letter (dated November 29, 2006). Affected customers were requested to return the FAX back form to I-Flow within 48 hours of receipt. The fax back form indicates the quantity of remaining product from each lot the customer may have.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 3475
- Distribution
- Nationwide
- Date initiated
- 2006-11-29
- Date posted
- 2007-01-18
- Date terminated
- 2009-12-11
- Location
- Lake Forest, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMEPUMP NSF (K932740) | Block Medical, Inc. | 1993-10-06 |