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U.S. Department of Health and Human Services

Class 3 Device Recall Prostate Seeding Needle for Use with the Mick Applicator

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  Class 3 Device Recall Prostate Seeding Needle for Use with the Mick Applicator see related information
Date Initiated by Firm May 03, 2005
Date Posted June 22, 2005
Recall Status1 Terminated 3 on August 29, 2005
Recall Number Z-0922-05
Recall Event ID 31963
510(K)Number K902622  
Product Classification Source, Brachytherapy, Radionuclide - Product Code KXK
Product Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows:
a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090
Code Information Part number B0140286, lot numbers 0747, 0839, 0840, 3412, 3413, 3414, 3415, 4078, 4088 and 4089; Part number 2380US-18E-17, lot number 0015
Recalling Firm/
Manufacturer		 Manan Medical Products, Inc.
241 W Palatine Rd
Wheeling IL 60090-5824
For Additional Information Contact
800-424-6779
Manufacturer Reason
for Recall		 The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
FDA Determined
Cause 2		 Other
Action Manan Medical sent recall letters to their bulk needle customers on 5/3/05, informing them of Mick Radio-Nuclear''s recall of their Prostate Seeding Needles manufactured by Manan due to the out of specification needle hub sticking in the applicator. The accounts were informed that the needles manufactured for them were made using the same mold as the Mick needle, and were requested to return the affected lot numbers to Manan for replacement.
Quantity in Commerce 22,900 units
Distribution Florida and Georgia
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 = MANAN MEDICAL PRODUCTS, INC.
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