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U.S. Department of Health and Human Services

Class 2 Device Recall Rapid Strand Rx

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  Class 2 Device Recall Rapid Strand Rx see related information
Date Initiated by Firm September 20, 2011
Date Posted November 22, 2011
Recall Status1 Terminated 3 on January 20, 2012
Recall Number Z-0266-2012
Recall Event ID 60005
510(K)Number K063177  
Product Classification Source, brachytherapy, radionuclide - Product Code KXK
Product Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, 3350 North Ridge Avenue, Arlington Heights, IL 60004 USA, Prescription Filled by: AnazaoHealth, 5710 Hoover Blvd., Tampa, FL 33634 USA; product identifier: I125RSRX, model 7000.

RAPID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy.
Code Information product identifier: I125RSRX, Oncura order numbers 85342, 85778, 85897, 87430, 87433, 87479, 87547, 87801, 87849, 87851, 87992, 87993, 88070, 88081, 88093, 88426, 88562, 88690, 88798, 88819, 88823, 88830 and 88844.
Recalling Firm/
Medi-Physics Inc. dba GE Healthcare
3350 N Ridge Ave
Arlington Heights IL 60004-1412
For Additional Information Contact
Manufacturer Reason
for Recall
There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.
FDA Determined
Cause 2
Process control
Action GE Healthcare/Oncura sent a "Urgent Medical Device Correction" letter dated September 20, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were advised to assess the pre and post plan dosimetry for their patient, taking into account the possible variation of the seed strength. GE Healthcare/Oncura will contact the customers in the near future to confirm their receipt of the letter and to discuss any questions they may have. Please call if you have any further questions (847) 398-8400 and 011-44-1494-737251 (Amersham, United Kingdom, GMT)
Quantity in Commerce 23 orders
Distribution Worldwide Distribution -- USA (nationwide) including the States of Arizona, Florida, Louisiana, Mississippi, New Jersey, New York, Pennsylvania, Puerto Rico, Virginia and Washington, and the countries of Canada and the United Kingdom
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.
510(K) Database 510(K)s with Product Code = KXK and Original Applicant = ONCURA INC.