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U.S. Department of Health and Human Services

Class 3 Device Recall Mick TP Prostate Seeding Needle

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 Class 3 Device Recall Mick TP Prostate Seeding Needlesee related information
Date Initiated by FirmMarch 30, 2005
Date PostedJune 01, 2005
Recall Status1 Terminated 3 on August 22, 2012
Recall NumberZ-0857-05
Recall Event ID 32046
510(K)NumberK890341 
Product Classification Needle, Isotope, Gold, Titanium, Platinum - Product Code IWF
ProductMick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- BRAND NAME: Mick TP Disposable Needle 18 Gauge. COMMON/USUAL NAME: TP Needle 18 Gauge. CLASSIFICATION NAME: System, Applicator, Radionuclide, Manual. --- The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each.
Code Information Lots: M121504-07 (Exp. 12/15/09), M012605-01 (Exp. 1/26/10), M012805-01 (Exp. 1/28/10); --- 8/09/05 RECALL EXPANSION (7 Lots): M110204-01 (Exp. 11/02/09), M110204-04 (Exp. 11/02/09), M110504-02 (Exp. 11/05/09), M120804-01 (Exp. 12/08/09), M120904-01 (Exp. 12/09/09), M121004-03 (Exp. 12/10/09), M121404-01 (Exp. 12/14/09)
Recalling Firm/
Manufacturer		 Mick Radio Nuclear Instr Inc
521 Homestead Avenue
Mount Vernon NY 10550-4619
For Additional Information ContactKenneth Zabrouski
914-667-3999
Manufacturer Reason
for Recall		Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator. Firm received one complaint during use of the Mick 200 TPV Applicator.
FDA Determined
Cause 2		Other
ActionRecall Notices (dated 3/30/05) were sent to the consignees by First Class Mail on 3/30/05. Follow-up phone calls to the consignees were initiated on 4/22/05. Recall was expanded for 7 additional lots, and recall notices (dated 8/09/05) were sent to the direct consignees (medical facilities).
Quantity in Commerce327 cartons; RECALL EXPANSION: 926 cartons
DistributionMedical facilities located nationwide, and distributors in Sweden, The Netherlands, Germany and the United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IWF
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