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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Convenience Kit

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  Class 2 Device Recall Custom Convenience Kit see related information
Date Initiated by Firm October 15, 2004
Date Posted November 11, 2004
Recall Status1 Terminated 3 on December 15, 2004
Recall Number Z-0191-05
Recall Event ID 30343
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Custom Convenience Kit
Code Information Catalog # K09-00318FP, Lot # A348888 Catalog # K09-00378R, Lot #''s A335890, A337933, A339213, A342799, A345077, A347860. Catalog # k09-00946MP, Lot # A353710. Catalog # K09-01732HP, Lot #''s A341495, A348992. Catalog # K09-03251TP, Lot # A347976. Catalog # K09-05064D, Lot # A343197. Catalog # K09-05218BP, Lot # A347495. Catalog # K09-05475DP, Lot #''s A340512, A343609, A350138. Catalog # K09-05588C, Lot # A342348. Catalog # K09-05604DP, Lot #A339243. Catalog # K09-05608DP, Lot #''s A339690, A349600. Catalog # K09-05894F, Lot # A342805. Catalog # K09-07970A, Lot #''s A342665, A345567. Catalog # K09-08150AP, Lot #A340352. Catalog # K09-90100T, Lot # A353161. Catalog # K10-00091MP, Lot # A349569. Catalog # K10-01684BP, Lot # A352021. Catalog # K10-02936CP, Lot # A349696. Catalog # K10-03091B, Lot # A347572.  Catalog # K10-03237AP, Lot #''s A339280, A348945. Catalog # K10-03247P, Lot # A347910. Catalog # K10-03256P, Lot #''s A345788, A350183. Catalog # K10-03281P, Lot #''s A346956, A348009. Catalog # K12-01191C, Lot # A347022. Catalog # K12-01242P, Lot # A350194. Catalog # K12-01304P, Lot #''s A346945, A349053, A350907. Catalog # K12-01356P, Lot #''s A343540, A351436. Catalog # K12-01372P, Lot #''s A343539, A346944. Catalog # K12-01402P, Lot # A352329. Catalog # K12-01427P, Lot # A352036. Catalog # K12-01507P, Lot #''s A349066, A351446. Catalog # K12-01512, Lot # A348216. Catalog # K12-01560, Lot # A347564.
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc
1600 West Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
801-253-1600
Manufacturer Reason
for Recall		 Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare.These needles may detach from their hub during use.
FDA Determined
Cause 2		 Other
Action All consignees were notified by sales reps either by visit or telephone beginning 10/18/2004
Quantity in Commerce 10202 kits
Distribution Nationwide. No foreign distribution
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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