Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
FDA device recall Z-1721-2009 · posted 2009-08-20 · Terminated
Recall details
- Recalling firm
- Med Tec Inc
- Reason for recall
- The silkscreened indexing scale was reversed.
- Action taken
- Med Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a "Recall Notification" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable. Foreign customers were notified by e-mail or phone beginning March 16, 2009. For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- IXQ
- Quantity affected
- 231 units
- Distribution
- Worldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexic
- Date initiated
- 2009-03-06
- Date posted
- 2009-08-20
- Date terminated
- 2009-11-05
- Location
- Orange City, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARBON FIBER CONFORMAL COUCH TOP (K973842) | Medtec, Inc. | 1997-12-05 |