FDA Device recall Z-1074-2018
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA)
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA) by Smiths Medical Asd, citing 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 8.5….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1074-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-04 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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)
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.
Identifiers
| 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…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) |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1074-2018%22
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