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)
FDA Recall Z-1074-2018 · Posted 2018-03-15
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Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeLJT
Date Initiated2017-12-04
Date Terminated2020-06-12
Product Quantity1,077 units total
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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