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)

Reason: 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.

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)

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