—#162308

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)

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K093414
Affected lot / code info: 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)

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.

Timeline

Recall initiated: 2017-12-04
Posted by FDA: 2018-03-15
Terminated: 2020-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162308. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.