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.
FDA Recall Z-0124-2010 · Posted 2009-11-06
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Recalling FirmMed Tec Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-08-31
Date Terminated2012-03-07
Product Quantity12 boxes
Reason for Recall
Some of the packages contain the incorrect mask style.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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