Recall Z-1721-2009
Med Tec Inc · initiated March 6, 2009
Product
Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
Codes / lots: Lot NNumbers: M055260, M042340, M024020, M022010 and M006980
Reason for recall
The silkscreened indexing scale was reversed.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-1721-2009
- Initiated
- March 6, 2009
- Posted by FDA
- August 20, 2009
- Terminated
- November 5, 2009
- Product code
- IXQ – Table, Radiographic, Stationary Top
- Quantity
- 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, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.
- Recalling firm
- Med Tec Inc, Orange City, IA