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U.S. Department of Health and Human Services

Class 3 Device Recall MTAPSD2.4 TypeS Thermoplastic Mask

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  Class 3 Device Recall MTAPSD2.4 TypeS Thermoplastic Mask see related information
Date Initiated by Firm February 25, 2008
Date Posted May 21, 2008
Recall Status1 Terminated 3 on July 02, 2008
Recall Number Z-1608-2008
Recall Event ID 46863
Product Classification Medical charged-particle radiation therapy system - Product Code IYE
Product 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.
Code Information Lot Number: 34415.
Recalling Firm/
Manufacturer		 Civco Medical Instruments Inc
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact James Leong
319-656-4447 Ext. 224
Manufacturer Reason
for Recall		 Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
FDA Determined
Cause 2		 Labeling mix-ups
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.
Quantity in Commerce 160
Distribution Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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