MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
FDA Recall Z-1608-2008 · Posted 2008-05-21
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Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-02-25
Date Terminated2008-07-02
Product Quantity160
Reason for Recall
Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
Firm Action
Consignees were notified by a Recall Notification letter on 2/25/08. The letter informed users that the recalling firm will replace the affected product. It also requested that users return a recall notification acknowledging notification of recall. Users were instructed to contact their sales representative to arrange servicing or for additional information at 1-800-842-8688.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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