FDA Device recall Z-1073-2018
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA)
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (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-1073-2018 |
| 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
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (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. 21-4071-24 (Lot No. 86X046, 87X050); b. Item No. 21-8066-24 (Lot No. 87X178); c. Item No. 21-8068-24 (Lot No. 87X179) |
|---|
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-1073-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.