CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.
Recall
- Recall Number
- Z-0124-2010
- Event Number
- 53142
- Firm
- Med Tec Inc
- FEI Number
- 1000143606
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 31, 2009
- Posted
- November 6, 2009
- Terminated
- March 7, 2012
- Address
- 1401 8th St PO Box 320, Orange City, IA, 51041-0320
Description
CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.
Some of the packages contain the incorrect mask style.
The recalling firm initiated their recall via letter dated 8/27/09 issued certified mail for the domestic customers and e-mail for the foreign customer. The communication informs the customer of the reason for recall and offers to replace the product. For questions or for return of the mask, a phone number is provided. A response form was enclosed with the letter for completion to indicate the amount of affected product in the possession of the customer and whether or not they plan to return it.
Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.
12 boxes