| Class 2 Device Recall Power PORTACATH | |
Date Initiated by Firm | December 04, 2017 |
Date Posted | March 15, 2018 |
Recall Status1 |
Terminated 3 on June 12, 2020 |
Recall Number | Z-1074-2018 |
Recall Event ID |
79429 |
510(K)Number | K093414 |
Product Classification |
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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Product | Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as:
a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA);
b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA);
c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA);
d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA);
e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA);
f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA);
g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA) |
Code Information |
a. Item No. 21-4474-24 (Lot No. 87X040, 87X117); b. Item No. 21-4475-24 (Lot No. 87X044); c. Item No. 21-4477-24 (Lot No. 87X097); d. Item No. 21-8466-24 (Lot No. 87X171); e. Item No. 21-8468-24 (Lot No. 87X172, 87X244, 87X180); f. Item No. 21-8469-24 (Lot No. 87X151); g. Item No. 21-8470-24 (Lot No. 87X173, 87X254, 87X194, 87X198, 87X237) |
Recalling Firm/ Manufacturer |
Smiths Medical ASD Inc. 6000 Nathan Ln N Minneapolis MN 55442-1690
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For Additional Information Contact | 763-383-3072 |
Manufacturer Reason for Recall | Certain models and lots of PORT A CATH implantable
port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer. |
FDA Determined Cause 2 | Process design |
Action | Customers were notified via letter on about 12/04/2017. Instructions include to examine current inventory for affected product, collect and isolate any potentially affected product, determine the total number of potentially affected product in possession and complete and return the Urgent Medical Device Recall Response Form, return any affected product on hand, and notify customers if the affected products were further distributed. |
Quantity in Commerce | 1,077 units total |
Distribution | Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = LJT
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