Civco Medical Instruments Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Civco Medical Instruments Inc
Lot Codes / Batch Numbers
Lot Number: 34415.
Products Sold
Lot Number: 34415.
Civco Medical Instruments Inc is recalling MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposabl due to Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, IL, MA, MI, NC, PA, SD, TN, WI
Page updated: Jan 10, 2026